A Trial Comparing NNC0148-0287 C (Insulin 287) Versus Insulin Glargine U100, Both in Combination With Metformin, With or Without DPP4 Inhibitors and With or Without SGLT2 Inhibitors, in Insulin-naïve Subjects With Type 2 Diabetes Mellitus

A Research Study to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine in People With Type 2 Diabetes Who Have Not Used Insulin Before

Sponsors

Lead sponsor: Novo Nordisk A/S

Source Novo Nordisk A/S
Brief Summary

This study compares insulin 287 (a possible new medicine) to insulin glargine (a medicine doctors can already prescribe) in people with type 2 diabetes. Different ways of changing the dose of insulin 287 are also compared. This is done to find the best way to change the dose of insulin 287. Participants will either get insulin 287 that they will have to inject once a week or insulin glargine that participants will have to inject once a day. Which treatment participants get is decided by chance. The study will last for about 5 months (23 weeks). Participants will have 14 clinic visits and 6 phone calls with the study doctor. At 3 of the clinic visits participants will be asked not to eat or drink anything (except for water) in the last 8 hours before the visit. During the study, the study doctor will ask participants to:

- measure blood sugar every day with a blood sugar meter using a finger prick.

- write down different information in a diary daily and return this to the study doctor.

- wear a medical device (sensor) that measure blood sugar all the time for 18 weeks (about 4 months) during the study.

Women cannot take part if pregnant, breastfeeding or plan to become pregnant during the study period.

Overall Status Completed
Start Date May 9, 2019
Completion Date January 17, 2020
Primary Completion Date December 12, 2019
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Time in target range 3.9-10.0 mmol/L (70-180 mg/dL) measured using CGM (continuous glucose monitoring) During the last 2 weeks of treatment (week 15 and 16)
Secondary Outcome
Measure Time Frame
Change in HbA1c (glycated haemoglobin) From baseline week 0 (V2) to week 16 (V18)
Change in fasting plasma glucose (FPG) From baseline week 0 (V2) to week 16 (V18)
Change in body weight From baseline week 0 (V2) to week 16 (V18)
Weekly insulin dose During the last 2 weeks of treatment (week 15 and 16)
Number of treatment emergent adverse events (TEAEs) From baseline week 0 (V2) to week 21 (V20)
Number of severe hypoglycaemic episodes (Level 3) From baseline week 0 (V2) to week 16 (V18)
Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) From baseline week 0 (V2) to week 16 (V18)
Number of hypoglycaemic alert episodes(level 1) (greater than or equal to 3.0 and below 3.9 mmol/L (greater than or equal to 54 and below 70 mg/dL), confirmed by BG meter) From baseline week 0 (V2) to week 16 (V18)
Enrollment 205
Condition
Intervention

Intervention type: Drug

Intervention name: Insulin 287

Description: Administered subcutaneously SC once weekly. Starting dose will be 70U.

Intervention type: Drug

Intervention name: Insulin Glargine

Description: Administered subcutaneously SC once daily.The starting dose will be 10U.

Arm group label: Insulin Glargine algorithm D

Eligibility

Criteria:

Inclusion Criteria:

- Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent

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

- HbA1c of 7.0-10.0% (53.0-85.8 mmol/mol) (both inclusive) as assessed by central laboratory

- Stable daily dose(s) for 90 days prior to the day of screening of any of the following antidiabetic drug(s) or combination regime(s):

1. Any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose (as documented in subject's medical records)

2. Free or fixed combination therapy: Metformin as outlined above plus/minus DPP4i with or without SGLT2i is allowed:

i) DPP4i (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose) ii) SGLT2i (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose )

- Insulin-naïve. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes

- Body mass index (BMI) below or equal to 40.0 kg/m^2

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Clinical Reporting Anchor and Disclosure (1452) Study Director Novo Nordisk A/S
Location
facility
Novo Nordisk Investigational Site | Anaheim, California, 92801, United States
Novo Nordisk Investigational Site | Lancaster, California, 93534, United States
Novo Nordisk Investigational Site | Roswell, Georgia, 30076, United States
Novo Nordisk Investigational Site | Statesboro, Georgia, 30461, United States
Novo Nordisk Investigational Site | Idaho Falls, Idaho, 83404-7596, United States
Novo Nordisk Investigational Site | Muncie, Indiana, 47304, United States
Novo Nordisk Investigational Site | Las Vegas, Nevada, 89128, United States
Novo Nordisk Investigational Site | West Seneca, New York, 14224, United States
Novo Nordisk Investigational Site | Chattanooga, Tennessee, 37411, United States
Novo Nordisk Investigational Site | Nashville, Tennessee, 37203, United States
Novo Nordisk Investigational Site | Austin, Texas, 78702, United States
Novo Nordisk Investigational Site | Austin, Texas, 78731, United States
Novo Nordisk Investigational Site | Dallas, Texas, 75231, United States
Novo Nordisk Investigational Site | Dallas, Texas, 75390-9302, United States
Novo Nordisk Investigational Site | Schertz, Texas, 78154, United States
Novo Nordisk Investigational Site | Karlovac, 47000, Croatia
Novo Nordisk Investigational Site | Osijek, 31 000, Croatia
Novo Nordisk Investigational Site | Rijeka, 51 000, Croatia
Novo Nordisk Investigational Site | Varazdin, 42 000, Croatia
Novo Nordisk Investigational Site | Bad Mergentheim, 97980, Germany
Novo Nordisk Investigational Site | Essen, 45136, Germany
Novo Nordisk Investigational Site | Falkensee, 14612, Germany
Novo Nordisk Investigational Site | Friedrichsthal, 66299, Germany
Novo Nordisk Investigational Site | Hamburg, 22607, Germany
Novo Nordisk Investigational Site | Münster, 48145, Germany
Novo Nordisk Investigational Site | Oldenburg I. Holst, 23758, Germany
Novo Nordisk Investigational Site | Pohlheim, 35415, Germany
Novo Nordisk Investigational Site | Saint Ingbert-Oberwürzbach, 66386, Germany
Novo Nordisk Investigational Site | Kaposvár, 7400, Hungary
Novo Nordisk Investigational Site | Szeged, H-6720, Hungary
Novo Nordisk Investigational Site | Zalaegerszeg, 8900, Hungary
Novo Nordisk Investigational Site | Bialystok, 15-435, Poland
Novo Nordisk Investigational Site | Lublin, 20-538, Poland
Novo Nordisk Investigational Site | Radom, 26-600, Poland
Novo Nordisk Investigational Site | Tomaszow Mazowiecki, 97-200, Poland
Novo Nordisk Investigational Site | Warszawa, 02-507, Poland
Novo Nordisk Investigational Site | Banska Bystrica, 97401, Slovakia
Novo Nordisk Investigational Site | Kosice, 040 01, Slovakia
Novo Nordisk Investigational Site | Nitra, 94911, Slovakia
Novo Nordisk Investigational Site | Rimavska Sobota, 97901, Slovakia
Novo Nordisk Investigational Site | Roznava, 04801, Slovakia
Novo Nordisk Investigational Site | Velky Meder, 93201, Slovakia
Novo Nordisk Investigational Site | Baracaldo, 48903, Spain
Novo Nordisk Investigational Site | La Coruña, 15006, Spain
Novo Nordisk Investigational Site | La Roca del Vallés, 08430, Spain
Novo Nordisk Investigational Site | Vic (Barcelona), 08500, Spain
Location Countries

Croatia

Germany

Hungary

Poland

Slovakia

Spain

United States

Verification Date

January 2020

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Arm group label: Insulin 287 algorithm A

Arm group type: Experimental

Description: Controlled on metformin with or without DPP4i (dipeptidyl peptidase-4 inhibitors) and with or without SGLT2i (sodium-glucose cotransporter 2 inhibitors).

Arm group label: Insulin 287 algorithm B

Arm group type: Experimental

Description: Controlled on metformin with or without DPP4i and with or without SGLT2i.

Arm group label: Insulin 287 algorithm C

Arm group type: Experimental

Description: Controlled on metformin with or without DPP4i and with or without SGLT2i.

Arm group label: Insulin Glargine algorithm D

Arm group type: Active Comparator

Description: Controlled on metformin with or without DPP4i and with or without SGLT2i.

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov