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A Research Study to Compare Insulin 287 Once a Week to Insulin Glargine (100 Units/mL) Once a Day in People With Type 2 Diabetes.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03751657
Recruitment Status : Completed
First Posted : November 23, 2018
Last Update Posted : March 6, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
The study compares 2 medicines for people with type 2 diabetes: insulin 287 (a new medicine) and insulin glargine (a medicine doctors can already prescribe). The study doctors will test insulin 287 to see how well it works compared to insulin glargine. The study will also test if insulin 287 is safe. The study participants will either get insulin 287 or insulin glargine (100 units/mL) - which treatment the participants get is decided by chance. The participants will need to inject their selves every day about the same time. Once a week the participant will need to take 1 extra injection on the same day of the week. The participants will have 16 clinic visits and 14 phone calls with the study doctor. During the study, the doctors will ask you to: 1) measure your blood sugar every day with a blood glucose meter using a finger prick, 2) write down different information in a paper diary daily and return this to your doctor, 3) wear a medical device to measure your blood sugar all the time for 2 weeks 5 times during the study.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Insulin 287 Drug: Placebo (insulin 287) Drug: Metformin Drug: Dipeptidyl peptidase-4 inhibitors Drug: Insulin glargine Drug: Placebo (insulin glargine) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 247 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Primary Purpose: Treatment
Official Title: An Investigational Trial Comparing the Efficacy and Safety of Once Weekly NNC0148-0287 C (Insulin 287) Versus Once Daily Insulin Glargine, Both in Combination With Metformin, With or Without DPP-4 Inhibitors, in Insulin naïve Subjects With Type 2 Diabetes Mellitus
Actual Study Start Date : November 29, 2018
Actual Primary Completion Date : December 16, 2019
Actual Study Completion Date : January 17, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Insulin 287
Participants will receive once weekly insulin 287 and once daily placebo in combination with metformin with or without dipeptidyl peptidase-4 inhibitors (DPP4i) during 26 weeks of treatment period.
Drug: Insulin 287
Insulin 287 once weekly subcutaneous (s.c.) injections at the starting dose of 70 units. Dose adjustment was done for the individual patient based on the three pre-breakfast self-measured plasma glucose values measured on two days prior to titration and on the day of the contact. The insulin dose adjustment should aim to reach an SMPG of 3.9-6.0 mmol/L (70-108 mg/dL)

Drug: Metformin
Metformin is considered as non investigational medicinal product. Subject will continue metformin at stable pre-trial dose.

Drug: Dipeptidyl peptidase-4 inhibitors
Dipeptidyl peptidase-4 inhibitors are considered as non investigational medicinal products. Subject will continue dipeptidyl peptidase-4 inhibitor at stable pre-trial dose.

Drug: Placebo (insulin glargine)
Participants will receive once daily s.c. injections of placebo equivalent to insulin glargine.

Active Comparator: Insulin glargine
Participants will receive once daily insulin glargine and once weekly placebo in combination with metformin with or without DPP4i during 26 weeks of treatment period.
Drug: Placebo (insulin 287)
Participants will receive once weekly s.c. injections of placebo equivalent to insulin 287.

Drug: Metformin
Metformin is considered as non investigational medicinal product. Subject will continue metformin at stable pre-trial dose.

Drug: Dipeptidyl peptidase-4 inhibitors
Dipeptidyl peptidase-4 inhibitors are considered as non investigational medicinal products. Subject will continue dipeptidyl peptidase-4 inhibitor at stable pre-trial dose.

Drug: Insulin glargine
Insulin glargine (100 U/mL) once daily s.c. injections at the starting dose of 10 units. Dose adjustment will be done for the individual patient based on the three pre-breakfast self-measured plasma glucose values measured on two days prior to titration and on the day of the contact. The insulin dose adjustment should aim to reach an SMPG of 3.9-6.0 mmol/L (70-108 mg/dL).




Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: From baseline (week 0) to week 26 ]
    Measured in % points

  2. Change in HbA1c [ Time Frame: From baseline (week 0) to week 26 ]
    Measured in mmol/mol


Secondary Outcome Measures :
  1. Change in fasting plasma glucose [ Time Frame: From baseline (week 0) to week 26 ]
    Measured in mmol/l

  2. 9-point profile (individual self-measured plasma glucose values) [ Time Frame: Week 26 ]
    Measured on mmol/l

  3. Change in mean of the 9-point profile [ Time Frame: From baseline (week 0) to week 26 ]
    Measured in mmol/l. Mean of the 9-point profile is defined as the area under the profile.

  4. Fluctuations of the 9-point profile [ Time Frame: Week 26 ]
    Measured in mmol/l. Fluctuations of the 9-point profile is defined as the integrated absolute distance from the mean profile value divided by measurement time

  5. Change in fasting C-peptide [ Time Frame: From baseline (week 0) to week 26 ]
    Measured in mmol/l

  6. Change in body weight [ Time Frame: From baseline (week 0) to week 26 ]
    Measured in Kilogram

  7. Weekly dose of insulin 287 [ Time Frame: Week 24-26 ]
    Measured in Units

  8. Weekly dose of insulin glargine [ Time Frame: Week 24-26 ]
    Measured in Units

  9. Number of treatment emergent adverse events (TEAEs) [ Time Frame: From baseline (week 0) to week 31 ]
    Number of events

  10. Number of hypoglycaemic alert episodes [ Time Frame: From baseline (week 0) to week 26 ]
    Number of events. Hypoglycaemic alert episodes (level 1): Blood glucose greater than or equal to 3.0 and less than 3.9 mmol/L (greater than or equal to 54 and less than 70 mg/dL), confirmed by blood glucose meter.

  11. Number of clinically significant hypoglycaemic episodes [ Time Frame: From baseline (week 0) to week 26 ]
    Number of events. Clinically significant hypoglycaemic episodes (level 2): Blood glucose less than 3.0 mmol/L (less than 54 mg/dL), confirmed by blood glucose meter or severe hypoglycaemic episodes (level 3)

  12. Number of severe hypoglycaemic episodes [ Time Frame: From baseline (week 0) to week 26 ]
    Number of events

  13. Change in anti-insulin 287 antibodies level [ Time Frame: From baseline (week 0) to week 31 ]
    Measured in %B/T (bound radioactivity-labelled insulin 287/Total added radioactivity-labelled insulin 287)

  14. Change in anti-insulin 287 antibody titres [ Time Frame: From baseline (week 0) to week 31 ]
    Blood samples will be analysed for anti-insulin 287 antibodies. Confirmed anti-insulin 287 will have an antibody titre value determined.

  15. Change in cross-reactive anti-human insulin antibody status (positive/negative) [ Time Frame: From baseline (week 0) to week 31 ]
    Change in status (positive or negative) of cross-reactive anti-human insulin antibodies measured as number of participants in each status-category.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 7.0-9.5% (53-80 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): Any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose (as documented in subject's medical record) OR Any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose (as documented in subject medical record) with Dipeptidyl peptidase-4 inhibitor (DPP4i) (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose (as documented in subject's medical records)
  • 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) less than or equal to 40.0 kg/m^2

Exclusion Criteria:

  • Any episodes of diabetic ketoacidosis within the past 90 days prior to the day of screening and between screening and randomisation
  • Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening and between screening and randomisation
  • Presently classified as being in New York Heart Association (NYHA) Class IV
  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. 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
  • Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids)
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and randomisation

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): NCT03751657


Locations
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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: NCT03751657    
Other Study ID Numbers: NN1436-4383
U1111-1208-4124 ( Other Identifier: World Health Organization (WHO) )
2018-000322-63 ( Registry Identifier: European Medicines Agency (EudraCT) )
First Posted: November 23, 2018    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: March 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

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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
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action