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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

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ClinicalTrials.gov Identifier: NCT03951805
Recruitment Status : Completed
First Posted : May 15, 2019
Results First Posted : January 8, 2021
Last Update Posted : April 5, 2021
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE May 10, 2019
First Posted Date  ICMJE May 15, 2019
Results First Submitted Date  ICMJE December 11, 2020
Results First Posted Date  ICMJE January 8, 2021
Last Update Posted Date April 5, 2021
Actual Study Start Date  ICMJE May 9, 2019
Actual Primary Completion Date December 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2020)
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) [ Time Frame: During the last 2 weeks of treatment (week 15 and 16) ]
The percentage of time spent in glycaemic target range was calculated as 100 times the number of recorded measurements in glycaemic target range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive divided by the total number of recorded measurements. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was considered exposed to trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication). The endpoint is based on data recorded by CGM system. It was required that at least 70% of the planned CGM measurements during weeks 15-16 were available for endpoint data to be included in the analysis.
Original Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
Time in target range 3.9-10.0 mmol/L (70-180 mg/dL) measured using CGM (continuous glucose monitoring) [ Time Frame: During the last 2 weeks of treatment (week 15 and 16) ]
Percent
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2020)
  • Change in HbA1c (Glycated Haemoglobin) [ Time Frame: From baseline week 0 (visit 2) to week 16 (visit 18) ]
    Estimated mean change in HbA1c from baseline (week 0, visit 2) to end of treatment (week 16, visit 18) is presented. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was considered exposed to trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication).
  • Change in Fasting Plasma Glucose (FPG) [ Time Frame: From baseline week 0 (visit 2) to week 16 (visit 18) ]
    Estimated mean change in FPG from baseline (week 0, visit 2) to end of treatment (week 16, visit 18) is presented. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was considered exposed to trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication).
  • Change in Body Weight [ Time Frame: From baseline week 0 (visit 2) to week 16 (visit 18) ]
    Estimated mean change in body weight from baseline (week 0, visit 2) to end of treatment (week 16, visit 18) is presented. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was considered exposed to trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication).
  • Weekly Insulin Dose [ Time Frame: During the last 2 weeks of treatment (week 15 and 16) ]
    Estimated mean average weekly insulin dose during the last 2 weeks of treatment is presented. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was considered exposed to trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication).
  • Number of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: From baseline week 0 (visit 2) to week 21 (visit 20) ]
    A TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period. The on-treatment observation period was the time period from first dose of trial product (week 0, visit 2) until the follow-up visit (week 21, visit 20) or the last date on trial product + 5 weeks for once daily insulin and +6 weeks for once weekly insulin.
  • Number of Severe Hypoglycaemic Episodes (Level 3) [ Time Frame: From baseline week 0 (visit 2) to week 16 (visit 18) ]
    Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. Number of severe hypoglycaemic episodes that occurred from baseline (week 0, visit 2) to end of treatment (week 16, visit 18) are presented.
  • 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) [ Time Frame: From baseline week 0 (visit 2) to week 16 (visit 18) ]
    Clinically significant hypoglycaemic episodes (level 2) were defined as episodes that were sufficiently low to indicate serious, clinically important hypoglycaemia with plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL). Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. Number of clinically significant hypoglycaemic episodes (level 2), confirmed by blood glucose (BG) meter or severe hypoglycaemic episodes (level 3) that occured from baseline (week 0, visit 2) to end of treatment (week 16, visit 18) are presented.
  • 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) [ Time Frame: From baseline week 0 (visit 2) to week 16 (visit 18) ]
    Hypoglycaemia alert value (level 1) was defined as episodes that were sufficiently low for treatment with fast-acting carbohydrate and dose adjustment of glucose-lowering therapy with plasma glucose value of equal to or above (>=) 3.0 and < 3.9 mmol/L (>= 54 and < 70 mg/dL) confirmed by BG meter. Number of hypoglycaemic alert episodes (level 1) that occured from baseline (week 0, visit 2) to end of treatment (week 16, visit 18) are presented.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • Change in HbA1c (glycated haemoglobin) [ Time Frame: From baseline week 0 (V2) to week 16 (V18) ]
    %-point
  • Change in fasting plasma glucose (FPG) [ Time Frame: From baseline week 0 (V2) to week 16 (V18) ]
    mmol/l
  • Change in body weight [ Time Frame: From baseline week 0 (V2) to week 16 (V18) ]
    Kg
  • Weekly insulin dose [ Time Frame: During the last 2 weeks of treatment (week 15 and 16) ]
    U
  • Number of treatment emergent adverse events (TEAEs) [ Time Frame: From baseline week 0 (V2) to week 21 (V20) ]
    Count of events
  • Number of severe hypoglycaemic episodes (Level 3) [ Time Frame: From baseline week 0 (V2) to week 16 (V18) ]
    Count of events
  • 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) [ Time Frame: From baseline week 0 (V2) to week 16 (V18) ]
    Count of events
  • 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) [ Time Frame: From baseline week 0 (V2) to week 16 (V18) ]
    Count of events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: Insulin icodec
    Administered subcutaneously SC once weekly. Starting dose will be 70U.
    Other Name: Insulin 287
  • Drug: Insulin Glargine
    Administered subcutaneously SC once daily.The starting dose will be 10U.
Study Arms  ICMJE
  • Experimental: Insulin 287 algorithm A
    Controlled on metformin with or without DPP4i (dipeptidyl peptidase-4 inhibitors) and with or without SGLT2i (sodium-glucose cotransporter 2 inhibitors).
    Intervention: Drug: Insulin icodec
  • Experimental: Insulin 287 algorithm B
    Controlled on metformin with or without DPP4i and with or without SGLT2i.
    Intervention: Drug: Insulin icodec
  • Experimental: Insulin 287 algorithm C
    Controlled on metformin with or without DPP4i and with or without SGLT2i.
    Intervention: Drug: Insulin icodec
  • Active Comparator: Insulin Glargine algorithm D
    Controlled on metformin with or without DPP4i and with or without SGLT2i.
    Intervention: Drug: Insulin Glargine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 22, 2020)
205
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2019)
200
Actual Study Completion Date  ICMJE January 17, 2020
Actual Primary Completion Date December 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Croatia,   Germany,   Hungary,   Poland,   Slovakia,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03951805
Other Study ID Numbers  ICMJE NN1436-4465
U1111-1219-5474 ( Other Identifier: World Health Organization (WHO) )
2018-003406-11 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP