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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.

A Research Study of How Overdosing of a New Once Weekly Medicine NNC0148-0287 C (Insulin 287) Influences the Blood Sugar Level in People With Type 2 Diabetes

Clinicaltrials.gov identifier NCT03945656

Recruitment Status Recruiting

First Posted May 10, 2019

Last update posted April 6, 2020

Study Description

Brief summary:

This study is comparing the effect of a long-acting insulin analogue (insulin 287) with insulin glargine (Lantus®) in subjects with type 2 diabetes. In addition, the study is looking at symptoms of low blood sugar, awareness of low blood sugar and the time and amount of glucose needed to recover from low blood sugar after injecting 2 and 3 times the basal dose of insulin 287 and glargine. The purpose of the study is to make a once-weekly injectable basal insulin treatment for people with type 2 diabetes. Participants will get insulin 287 as well as insulin glargine - which treatment any participant gets first is decided by chance. Insulin 287 is a new medicine; insulin glargine can already be prescribed. The study medicines will be in a pen, and must be injected with a needle in the thigh once per day (insulin glargine) or once per week (insulin 287). The study will last for minimum 3 months and up to approximately 6 months. Participants will have 21 clinic visits and at least 2 phone calls with the study doctor. The participants' health will be monitored carefully and blood samples will be taken at the clinic visits.

  • Condition or Disease:Diabetes Mellitus, Type 2
  • Intervention/Treatment: Drug: Insulin 287
    Drug: Insulin glargine
  • Phase: Phase 1
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 43 participants
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Trial Investigating the Hypoglycaemic Response to Overdosing of NNC0148-0287 C (Insulin 287) in Subjects With Type 2 Diabetes
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: November 2020
  • Estimated Study Completion Date: November 2020
Arms and interventions
Arm Intervention/treatment
Experimental: Insulin 287 followed by insulin glargine
Run-in period (3 to 28 days): Once daily insulin glargine treatment with or without any usual metformin treatment. After run-in, participants will receive insulin 287 once a week (OW) for 6 weeks. After insulin 287 treatment, participants will receive insulin glargine U100 OD for 12 days.
Drug: Insulin 287
Participants will receive subcutaneous (s.c.) injections of insulin 287 OW for 6 weeks

Drug: Insulin glargine
Participants will receive daily s.c. injections of insulin glargine U100 for 12 days
Active Comparator: Insulin glargine followed by insulin 287
Run-in period (3 to 28 days): Once daily insulin glargine treatment with or without any usual metformin treatment. After run-in, participants will receive insulin glargine U100 OD for 12 days. After insulin glargine treatment, participants will receive insulin 287 OW for 6 weeks.
Drug: Insulin 287
Participants will receive subcutaneous (s.c.) injections of insulin 287 OW for 6 weeks

Drug: Insulin glargine
Participants will receive daily s.c. injections of insulin glargine U100 for 12 days
Outcome Measures
  • Primary Outcome Measures: 1. Clinically significant hypoglycaemia (Double dose): Clinically significant hypoglycaemia (Plasma glucose [PG] less than 3.0 mmol/L [54 mg/dL]) after 2 times the individualised optimal basal dose of insulin [ Time Frame: From start of hypoglycaemia induction after 2 times the individualised optimal basal dose of insulin (day 17 for insulin 287, day 4 for insulin glargine) until termination of the clamp the following day ]
    Yes/No Blood sugar lower than 3.0 mmol/L (54 mg/dL) after receiving a double dose of basal insulin Number of subjects experiencing an event is to be reported
  • Secondary Outcome Measures: 1. PG (nadir) - PG concentration at nadir after 2 and 3 times the individualised optimal basal dose of insulin [ Time Frame: From start of hypoglycaemia induction after 2 and 3 times the individualised optimal basal dose of insulin (day 17/day 38 for insulin 287, day 4/day 11 for insulin glargine) until termination of the clamp the following day ]
    Measured in mmol/L Minimum blood sugar level achieved after receiving a double or triple dose of basal insulin
  • 2. t (decline, PG 5.5 mmol/L - PG 3.0 mmol/L) - Time from start of hypoglycaemia induction until a PG concentration of 3.0 mmol/L (54 mg/dL) is reached after 2 and 3 times the individualised optimal basal dose of insulin [ Time Frame: From start of hypoglycaemia induction after 2 and 3 times the individualised optimal basal dose of insulin (day 17/day 38 for insulin 287, day 4/day 11 for insulin glargine) until termination of the clamp the following day ]
    Measured in hours Time from when blood sugar is normal [5.5 mmol/L (100 mg/dL)] until blood sugar is 3.0 mmol/L (54 mg/dL) after receiving a double or triple dose of basal insulin
  • 3. t (decline, PG 5.5 mmol/L - PG nadir) - Time from start of hypoglycaemia induction until PGnadir is reached after 2 and 3 times the individualised optimal basal dose of insulin [ Time Frame: From start of hypoglycaemia induction after 2 and 3 times the individualised optimal basal dose of insulin (day 17/day 38 for insulin 287, day 4/day 11 for insulin glargine) until termination of the clamp the following day ]
    Measured in hours Time from when blood sugar is normal [5.5 mmol/L (100 mg/dL)] until blood sugar is at a minimum level after receiving a double or triple dose of basal insulin
  • 4. t (recovery, PG nadir - PG 5.5 mmol/L) - Time to increase from PGnadir to a PG concentration of 5.5 mmol/L (100 mg/dL) after 2 and 3 times the individualised optimal basal dose of insulin [ Time Frame: From start of hypoglycaemia induction after 2 and 3 times the individualised optimal basal dose of insulin (day 17/day 38 for insulin 287, day 4/day 11 for insulin glargine) until termination of the clamp the following day ]
    Measured in hours Time from when blood sugar is at a minimum level until blood sugar is normal [5.5 mmol/L (100 mg/dL)] during recovery from low blood sugar after receiving a double or triple dose of basal insulin
  • 5. C (glucagon, PG nadir) - Plasma glucagon concentration at PGnadir after 2 and 3 times the individualised optimal basal dose of insulin [ Time Frame: From start of hypoglycaemia induction after 2 and 3 times the individualised optimal basal dose of insulin (day 17/day 38 for insulin 287, day 4/day 11 for insulin glargine) until termination of the clamp the following day ]
    Measured in pg/mL Blood level of the glucagon hormone at the time point when blood sugar is at a minimum level after receiving a double or triple dose of basal insulin
  • 6. C (adrenaline, PG nadir) - Plasma adrenaline concentration at PGnadir after 2 and 3 times the individualised optimal basal dose of insulin [ Time Frame: From start of hypoglycaemia induction after 2 and 3 times the individualised optimal basal dose of insulin (day 17/day 38 for insulin 287, day 4/day 11 for insulin glargine) until termination of the clamp the following day ]
    Measured in pg/mL Blood level of the adrenaline hormone at the time point when blood sugar is at a minimum level after receiving a double or triple dose of basal insulin
  • 7. C (noradrenaline, PG nadir) - Plasma noradrenaline concentration at PGnadir after 2 and 3 times the individualised optimal basal dose of insulin [ Time Frame: From start of hypoglycaemia induction after 2 and 3 times the individualised optimal basal dose of insulin (day 17/day 38 for insulin 287, day 4/day 11 for insulin glargine) until termination of the clamp the following day ]
    Measured in pg/mL Blood level of the noradrenaline hormone at the time point when blood sugar is at a minimum level after receiving a double or triple dose of basal insulin
  • 8. C (growth hormone [GH], PG nadir) - Serum growth hormone concentration at PGnadir after 2 and 3 times the individualised optimal basal dose of insulin [ Time Frame: From start of hypoglycaemia induction after 2 and 3 times the individualised optimal basal dose of insulin (day 17/day 38 for insulin 287, day 4/day 11 for insulin glargine) until termination of the clamp the following day ]
    Measured in ng/mL Blood level of GH at the time point when blood sugar is at a minimum level after receiving a double or triple dose of basal insulin
  • 9. C (cortisol, PG nadir) - Serum cortisol concentration at PGnadir after 2 and 3 times the individualised optimal basal dose of insulin [ Time Frame: From start of hypoglycaemia induction after 2 and 3 times the individualised optimal basal dose of insulin (day 17/day 38 for insulin 287, day 4/day 11 for insulin glargine) until termination of the clamp the following day ]
    Measured in ng/mL Blood level of the cortisol hormone at the time point when blood sugar is at a minimum level after receiving a double or triple dose of basal insulin
  • 10. Pulse (PG 5.5 mmol/L - PG nadir) - Change in pulse rate from a PG concentration of 5.5 mmol/L (100 mg/dL) until PGnadir after 2 and 3 times the individualised optimal basal dose of insulin [ Time Frame: From start of hypoglycaemia induction after 2 and 3 times the individualised optimal basal dose of insulin (day 17/day 38 for insulin 287, day 4/day 11 for insulin glargine) until termination of the clamp the following day ]
    Measured in beats/min Change in pulse from the time point when blood sugar is normal [5.5 mmol/L (100 mg/dL)] until the time point when blood sugar is at a minimum level after receiving a double or triple dose of basal insulin
  • 11. Diastolic blood pressure (DBP) (PG 5.5 mmol/L - PG nadir) - Change in diastolic blood pressure from a PG concentration of 5.5 mmol/L (100 mg/dL) until PGnadir after 2 and 3 times the individualised optimal basal dose of insulin [ Time Frame: From start of hypoglycaemia induction after 2 and 3 times the individualised optimal basal dose of insulin (day 17/day 38 for insulin 287, day 4/day 11 for insulin glargine) until termination of the clamp the following day ]
    Measured in mmHg Change in DBP from the time point when blood sugar is normal [5.5 mmol/L (100 mg/dL)] until the time point when blood sugar is at a minimum level after receiving a double or triple dose of basal insulin
  • 12. Systolic blood pressure (SBP) (PG 5.5 mmol/L - PG nadir) - Change in systolic blood pressure from a PG concentration of 5.5 mmol/L (100 mg/dL) until PGnadir after 2 and 3 times the individualised optimal basal dose of insulin [ Time Frame: From start of hypoglycaemia induction after 2 and 3 times the individualised optimal basal dose of insulin (day 17/day 38 for insulin 287, day 4/day 11 for insulin glargine) until termination of the clamp the following day ]
    Measured in mmHg Change in SBP from the time point when blood sugar is normal [5.5 mmol/L (100 mg/dL)] until the time point when blood sugar is at a minimum level after receiving a double or triple dose of basal insulin
  • 13. Digit Symbol Substitution Test (DSST) (PG 5.5 mmol/L - PG nadir) - Change in DSST score from a PG concentration of 5.5 mmol/L (100 mg/dL) until PGnadir after 2 and 3 times the individualised optimal basal dose of insulin [ Time Frame: From start of hypoglycaemia induction after 2 and 3 times the individualised optimal basal dose of insulin (day 17/day 38 for insulin 287, day 4/day 11 for insulin glargine) until termination of the clamp the following day ]
    Number of correct responses Change in performance in the DSST (a cognitive ability test) from the time point when blood sugar is normal [5.5 mmol/L (100 mg/dL)] until the time point when blood sugar is at a minimum level after receiving a double or triple dose of basal insulin
  • 14. Four-Choice Reaction Time (4CRT) (reaction 4CRT) (PG 5.5 mmol/L - PG nadir) - Change in 4CRT performance from a PG concentration of 5.5 mmol/L (100 mg/dL) until PGnadir after 2 and 3 times the individualised optimal basal dose of insulin [ Time Frame: From start of hypoglycaemia induction after 2 and 3 times the individualised optimal basal dose of insulin (day 17/day 38 for insulin 287, day 4/day 11 for insulin glargine) until termination of the clamp the following day ]
    Measured in msec Change in reaction time in the 4CRT test (a cognitive ability test) from the time point when blood sugar is normal [5.5 mmol/L (100 mg/dL)] until the time point when blood sugar is at a minimum level after receiving a double or triple dose of basal insulin
  • 15. 4CRT (% correct answers) (PG 5.5 mmol/L - PG nadir) - Change in 4CRT performance (% correct answers) from a PG concentration of 5.5 mmol/L (100 mg/dL) until PGnadir after 2 and 3 times the individualised optimal basal dose of insulin [ Time Frame: From start of hypoglycaemia induction after 2 and 3 times the individualised optimal basal dose of insulin (day 17/day 38 for insulin 287, day 4/day 11 for insulin glargine) until termination of the clamp the following day ]
    Measured in %-points Change in the percentage correct answers in the 4CRT test (a cognitive ability test) from the time point when blood sugar is normal [5.5 mmol/L (100 mg/dL)] until the time point when blood sugar is at a minimum level after receiving a double or triple dose of basal insulin
  • 16. Trail Making B test (TMB) (PG 5.5 mmol/L - PG nadir) - Change in TMB from a PG concentration of 5.5 mmol/L (100 mg/dL) until PGnadir after 2 and 3 times the individualised optimal basal dose of insulin [ Time Frame: From start of hypoglycaemia induction after 2 and 3 times the individualised optimal basal dose of insulin (day 17/day 38 for insulin 287, day 4/day 11 for insulin glargine) until termination of the clamp the following day ]
    Measured in sec Change in performance in the TMB (a cognitive ability test) from the time point when blood sugar is normal [5.5 mmol/L (100 mg/dL)] until the time point when blood sugar is at a minimum level after receiving a double or triple dose of basal insulin
  • 17. Hypoglycaemic symptoms score (HSS) (PG 5.5 mmol/L - PG nadir) - Change in HSS from a PG concentration of 5.5 mmol/L (100 mg/dL) to PGnadir after 2 and 3 times the individualised optimal basal dose of insulin [ Time Frame: From start of hypoglycaemia induction after 2 and 3 times the individualised optimal basal dose of insulin (day 17/day 38 for insulin 287, day 4/day 11 for insulin glargine) until termination of the clamp the following day ]
    Test score (arbitrary units) Change in symptoms of low blood sugar from the time point when blood sugar is normal [5.5 mmol/L (100 mg/dL)] until the time point when blood sugar is at a minimum level after receiving a double or triple dose of basal insulin
  • 18. Hypoglycaemia awareness (HA) (PG nadir) - HA at PGnadir after 2 and 3 times the individualised optimal basal dose of insulin [ Time Frame: From start of hypoglycaemia induction after 2 and 3 times the individualised optimal basal dose of insulin (day 17/day 38 for insulin 287, day 4/day 11 for insulin glargine) until termination of the clamp the following day ]
    Yes/No Number of subjects with a feeling of low blood sugar at the time point when blood sugar is at a minimum level after receiving a double or triple dose of basal insulin
  • 19. AUC (GIR, recovery, PG nadir -PG 5.5 mmol/L) - Area under the glucose infusion rate-time profile during recovery from PGnadir to a PG concentration of 5.5 mmol/L (100 mg/dL) after 2 and 3 times the individualised optimal basal dose of insulin [ Time Frame: From start of hypoglycaemia induction after 2 and 3 times the individualised optimal basal dose of insulin (day 17/day 38 for insulin 287, day 4/day 11 for insulin glargine) until termination of the clamp the following day ]
    Measured in mg/kg Amount of glucose needed to be infused to increase blood sugar from a minimum level to a normal level [5.5 mmol/L (100 mg/dL)] during recovery from low blood sugar after receiving a double or triple dose of basal insulin
  • 20. AUC (GIR, recovery, PG 5.5 mmol/L, 0-6h)-Area under the glucose infusion rate-time profile during 6 hours at a PG concentration of 5.5 mmol/L (100 mg/dL) after recovery from hypoglycaemia after 2 & 3 times the individualised optimal basal dose of insulin [ Time Frame: From start of hypoglycaemia induction after 2 and 3 times the individualised optimal basal dose of insulin (day 17/day 38 for insulin 287, day 4/day 11 for insulin glargine) until termination of the clamp the following day ]
    Measured in mg/kg Amount of glucose needed to be infused to keep blood sugar at a normal level [5.5 mmol/L (100 mg/dL)] for 6 hours after recovery from low blood sugar after receiving a double or triple dose of basal insulin
  • 21. Clinically significant hypoglycaemia (Triple dose) - Clinically significant hypoglycaemia [PG less than 3.0 mmol/L (54 mg/dL)], after 3 times the individualised optimal basal dose of insulin [ Time Frame: From start of hypoglycaemia induction after 3 times the individualised optimal basal dose of insulin (day 38 for insulin 287, day 11 for insulin glargine) until termination of the clamp the following day ]
    Yes/No Blood sugar lower than 3.0 mmol/L (54 mg/dL) after receiving a triple dose of basal insulin Number of subjects experiencing an event is to be reported
Eligibility Criteria
  • Ages Eligible for Study: 18 to 72 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Male or female, aged between 18 and 72 years (both inclusive) at the time of signing
informed consent.

- Body mass index between 18.5 and 37.9 kg/m^2 (both inclusive).

- Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the
day of screening.

- Glycosylated haemoglobin type A1c (HbA1c) less than or equal to 9.0% (less than or
equal to 74 mmol/mol) at screening.

- Current total daily insulin treatment between 0.2 and 1.0 U/kg/day (both inclusive).

Exclusion Criteria:

- Known or suspected hypersensitivity to trial products or related products.

- Female who is pregnant, breast-feeding or intends to become pregnant or is of
child-bearing potential and not using an adequate contraceptive method.

- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic,
gastrointestinal, endocrinological conditions (except conditions associated with
diabetes mellitus).

Contacts and Locations
Contacts

Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

Locations

Austria
Novo Nordisk Investigational Site
Graz

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S

More Information
  • Responsible Party: Novo Nordisk A/S
  • ClinicalTrials.gov Identifier: NCT03945656 History of Changes
  • Other Study ID Numbers: NN1436-4462, U1111-1214-2688, 2018-001993-74
  • First Posted: May 10, 2019 Key Record Dates
  • Last Update Posted: April 6, 2020
  • Last Verified: April 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
  • URL: http://novonordisk-trials.com
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Diabetes Mellitus Diabetes Mellitus, Type 2