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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 : Recruiting
First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Insulin 287 Drug: Insulin Glargine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 9, 2019
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : January 23, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).
Drug: Insulin 287
Administered subcutaneously SC once weekly. Starting dose will be 70U.

Experimental: Insulin 287 algorithm B
Controlled on metformin with or without DPP4i and with or without SGLT2i.
Drug: Insulin 287
Administered subcutaneously SC once weekly. Starting dose will be 70U.

Experimental: Insulin 287 algorithm C
Controlled on metformin with or without DPP4i and with or without SGLT2i.
Drug: Insulin 287
Administered subcutaneously SC once weekly. Starting dose will be 70U.

Active Comparator: Insulin Glargine algorithm D
Controlled on metformin with or without DPP4i and with or without SGLT2i.
Drug: Insulin Glargine
Administered subcutaneously SC once daily.The starting dose will be 10U.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in HbA1c (glycated haemoglobin) [ Time Frame: From baseline week 0 (V2) to week 16 (V18) ]
    %-point

  2. Change in fasting plasma glucose (FPG) [ Time Frame: From baseline week 0 (V2) to week 16 (V18) ]
    mmol/l

  3. Change in body weight [ Time Frame: From baseline week 0 (V2) to week 16 (V18) ]
    Kg

  4. Weekly insulin dose [ Time Frame: During the last 2 weeks of treatment (week 15 and 16) ]
    U

  5. Number of treatment emergent adverse events (TEAEs) [ Time Frame: From baseline week 0 (V2) to week 21 (V20) ]
    Count of events

  6. Number of severe hypoglycaemic episodes (Level 3) [ Time Frame: From baseline week 0 (V2) to week 16 (V18) ]
    Count of events

  7. 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

  8. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951805


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

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

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03951805     History of Changes
Other Study ID Numbers: NN1436-4465
U1111-1219-5474 ( Other Identifier: World Health Organization (WHO) )
2018-003406-11 ( Registry Identifier: European Medicines Agency (EudraCT) )
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Metformin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs