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A Research Study in People With Type 2 Diabetes to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine

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ClinicalTrials.gov Identifier: NCT03922750
Recruitment Status : Active, not recruiting
First Posted : April 22, 2019
Last Update Posted : December 2, 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 switching from the insulin which the participants are already on to insulin 287 are also compared. This is done to find the best way to switch to insulin 287. The participants will either get insulin 287 that they will have to inject once a week or insulin glargine that they will have to inject once a day. Which treatment any participant gets is decided by chance. The study will last for about 5 months (23 weeks). The 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 doctor will ask the participants to: 1) measure their blood sugar every day with a blood sugar meter using a finger prick; 2) write down different information in a diary daily and return this to their study doctor. 3) wear a medical device (sensor) that measures the participants blood sugar all the time for 18 weeks (about 4 months) during the study.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Insulin 287 Drug: Insulin glargine U100 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 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 Basal Insulin Treated Subjects With Type 2 Diabetes Mellitus
Actual Study Start Date : May 9, 2019
Estimated Primary Completion Date : December 19, 2019
Estimated Study Completion Date : January 23, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Insulin 287 (with 100% loading dose)
Participants will receive insulin 287 injections once weekly (OW). A unit to unit switch approach with an additional 100% loading dose of insulin 287 will be used.
Drug: Insulin 287
Participants will receive subcutaneous (s.c.) injections of Insulin 287 OW for 16 weeks.

Experimental: Insulin 287 (without loading dose)
Participants will receive insulin 287 injections OW. A unit to unit switch approach without loading dose of insulin 287 will be used.
Drug: Insulin 287
Participants will receive subcutaneous (s.c.) injections of Insulin 287 OW for 16 weeks.

Experimental: Insulin glargine U100
Participants will receive insulin glargine U100 once daily (OD).
Drug: Insulin glargine U100
Participants will receive s.c. injections of insulin glargine OD for 16 weeks




Primary Outcome Measures :
  1. Time in target range 3.9-10.0 mmol/L (70-180 mg/dL) measured using continuous glucose monitoring (CGM) [ Time Frame: During the last 2 weeks of treatment (Week 15 and 16) ]
    Measured in percent


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

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

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

  4. Weekly insulin dose [ Time Frame: During the last 2 weeks of treatment (week 15 and 16) ]
    Measured in 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) (less than 3.0 mmol/L (54 mg/dL), confirmed by blood glucose (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 mmol/L and less than 3.9 mmol/L (greater than or equal to 54 mg/dL and less than 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.
  • Glycosylated haemoglobin (HbA1c) of 7.0-10.0% (53.0-85.8 mmol/mol) (both inclusive) as assessed by central laboratory.
  • Treated with once daily or twice daily basal insulin analogue (insulin degludec, insulin detemir, insulin glargine U100 or U300, total daily dose of 10-50 U, both inclusive) greater than or equal to 90 days prior to the day of screening.
  • 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 with or without dipeptidyl peptidase 4 inhibitors (DPP4i) with or without sodium-glucose cotransporter 2 inhibitors (SGLT2i) is allowed: 1) DPP4i (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose); 2) SGLT2i (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose.
  • Body mass index (BMI) less than or equal to 40.0 kg/m^2.

Exclusion criteria:

  • Known or suspected hypersensitivity to trial product(s) or related products.
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method.
  • Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days before screening.
  • Any disorder, except for conditions associated with type 2 diabetes mellitus, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
  • Any episodes of diabetic ketoacidosis within the past 90 days prior to the day of screening and between screening and randomisation.
  • Known hypoglycaemic unawareness as indicated by the Investigator according to Clarke's questionnaire question 8.
  • Recurrent severe hypoglycaemic episodes within the last year as judged by the Investigator.
  • 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.

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): NCT03922750


  Show 38 Study Locations
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: NCT03922750     History of Changes
Other Study ID Numbers: NN1436-4466
U1111-1219-5541 ( Other Identifier: World Health Organization (WHO) )
2018-003407-18 ( Registry Identifier: European Medicines Agency (EudraCT) )
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 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
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs