Clinical trial NCT03951805: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2019-05-15
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Time in Target Range (TIR) 3.9-10.0 Millimoles Per Liter (mmol/L) (70-180 Milligrams Per Deciliter (mg/dL) Measured Using CGM (Continuous Glucose Monitoring)
timeFrame: During the last 2 weeks of treatment (week 15 and 16)
Secondary outcomes:
measure: Change in HbA1c (Glycated Haemoglobin)
timeFrame: From baseline week 0 (visit 2) to week 16 (visit 18)
measure: Change in Fasting Plasma Glucose (FPG)
timeFrame: From baseline week 0 (visit 2) to week 16 (visit 18)
measure: Change in Body Weight
timeFrame: From baseline week 0 (visit 2) to week 16 (visit 18)
measure: Weekly Insulin Dose
timeFrame: During the last 2 weeks of treatment (week 15 and 16)
measure: Number of Treatment Emergent Adverse Events (TEAEs)
timeFrame: From baseline week 0 (visit 2) to week 21 (visit 20)
measure: Number of Severe Hypoglycaemic Episodes (Level 3)
timeFrame: From baseline week 0 (visit 2) to week 16 (visit 18)
measure: Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Below 3.0 mmol/L (54 Milligrams Per Deciliter [mg/dL]), Confirmed by Blood Glucose (BG) Meter) or Severe Hypoglycaemic Episodes (Level 3)
timeFrame: From baseline week 0 (visit 2) to week 16 (visit 18)
measure: 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 Blood Glucose (BG) Meter)
timeFrame: From baseline week 0 (visit 2) to week 16 (visit 18)
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Lancaster
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Roswell
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Statesboro
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Las Vegas
country: United States
facility: Novo Nordisk Investigational Site
state: Nevada
city: West Seneca
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Chattanooga
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Schertz
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Karlovac
country: Croatia
facility: Novo Nordisk Investigational Site
city: Osijek
country: Croatia
facility: Novo Nordisk Investigational Site
city: Rijeka
country: Croatia
facility: Novo Nordisk Investigational Site
city: Varazdin
country: Croatia
facility: Novo Nordisk Investigational Site
city: Bad Mergentheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Essen
country: Germany
facility: Novo Nordisk Investigational Site
city: Falkensee
country: Germany
facility: Novo Nordisk Investigational Site
city: Friedrichsthal
country: Germany
facility: Novo Nordisk Investigational Site
city: Hamburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Münster
country: Germany
facility: Novo Nordisk Investigational Site
city: Oldenburg I. Holst
country: Germany
facility: Novo Nordisk Investigational Site
city: Pohlheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Saint Ingbert-Oberwürzbach
country: Germany
facility: Novo Nordisk Investigational Site
city: Kaposvár
country: Hungary
facility: Novo Nordisk Investigational Site
city: Szeged
country: Hungary
facility: Novo Nordisk Investigational Site
city: Zalaegerszeg
country: Hungary
facility: Novo Nordisk Investigational Site
city: Bialystok
country: Poland
facility: Novo Nordisk Investigational Site
city: Lublin
country: Poland
facility: Novo Nordisk Investigational Site
city: Radom
country: Poland
facility: Novo Nordisk Investigational Site
city: Tomaszow Mazowiecki
country: Poland
facility: Novo Nordisk Investigational Site
city: Warszawa
country: Poland
facility: Novo Nordisk Investigational Site
city: Banska Bystrica
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Kosice
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Nitra
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Rimavska Sobota
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Roznava
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Velky Meder
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Baracaldo
country: Spain
facility: Novo Nordisk Investigational Site
city: La Coruña
country: Spain
facility: Novo Nordisk Investigational Site
city: La Roca del Vallés
country: Spain
facility: Novo Nordisk Investigational Site
city: Vic (Barcelona)
country: Spain
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References:
citation: Lingvay I, Buse JB, Franek E, Hansen MV, Koefoed MM, Mathieu C, Pettus J, Stachlewska K, Rosenstock J. A Randomized, Open-Label Comparison of Once-Weekly Insulin Icodec Titration Strategies Versus Once-Daily Insulin Glargine U100. Diabetes Care. 2021 Jul;44(7):1595-1603. doi: 10.2337/dc20-2878. Epub 2021 Apr 19.