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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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The purpose of the study is to determine whether in patients with early type 2 diabetes, a short-term intensive metabolic intervention comprising IDegLira, metformin, and lifestyle approaches will be superior to standard diabetes therapy in achieving sustained diabetes remission.
This is a multicentre, open-label, randomized controlled trial in 160 patients with recently-diagnosed T2DM. Participants will be randomized to 2 treatment groups: (a) a 16-week course of treatment with IDegLira, metformin and lifestyle therapy, and (b) standard diabetes therapy, and followed for a total of 68 weeks (1 year and 4 months). In all participants with HbA1C<7.3% at the 16 week visit, glucose-lowering medications will be discontinued and participants will be encouraged to continue with lifestyle modifications and regular glucose monitoring. Participants with HbA1C ≥ 7.3% at this visit or who experience hyperglycemia relapse after stopping drugs will receive standard glycemic management as informed by the current Canadian Diabetes Association clinical practice guidelines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Drug: IDegLira - sc injection; Drug: metformin - oral administration; Drug: insulin degludec - sc injection; Behavioral: lifestyle therapy, diet and exercise |
|
| Standard Care | No Intervention | Standard glycemic care as informed by the current clinical practice guidelines |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDegLira | Drug | Dose is titrated to achieve fasting normoglycemia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving drug-free diabetes remission | Drug-free diabetes remission is defined as HbA1C < 6.5 % off glucose-lowering agents for at least 12 weeks. | 28 weeks after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving drug-free diabetes remission | 28 weeks, 40 weeks, 52 weeks and 68 weeks after randomization | |
| Proportion of participants achieving drug-free normoglycemia | defined as HbA1C < 6.0% off glucose-lowering agents for at least 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| the time interval from randomization until any glucose lowering drug is restarted or relapse of hyperglycemia | Up to week 68 | |
| the time interval from the 16 week visit (i.e. when glucose lowering drugs are to be stopped) until any glucose lowering drug is restarted or relapse of hyperglycemia |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zubin Punthakee, MD | McMaster University | Principal Investigator |
| Hertzel Gerstein, MD | McMaster University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2T 5C7 | Canada | ||
| University of Alberta |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000613158 | IDegLira |
| C571886 | insulin degludec |
| D008687 | Metformin |
| D004032 | Diet |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D009747 |
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| insulin degludec | Drug | In those who need additional insulin or who cannot tolerate IDegLira, insulin degludec will be used. Dose is titrated to achieve fasting normoglycemia. |
|
| Metformin | Drug | Dose is titrated to 2000 mg per day or maximal tolerated dose |
|
| Lifestyle Therapy | Behavioral | Lifestyle intervention includes individualized dietary and exercise advice targeting at least 5% weight loss with frequent visits and coaching for goal reinforcement, behavior modification and problem-solving |
|
|
| 28 weeks, 40 weeks, 52 weeks and 68 weeks after randomization |
| Proportion of participants achieving drug-free diabetes regression | defined as HbA1C <7.0% off glucose-lowering agents for at least 12 weeks. | 28 weeks, 40 weeks, 52 weeks and 68 weeks after randomization |
| Up to week 68 |
| the change in HbA1c | 16, 28, 40, 52 and 68 week visit as well as the overall change |
| the change in weight | 16, 28, 40, 52 and 68 week visit as well as the overall change |
| the change in waist circumference | 16, 28, 40, 52 and 68 week visit as well as the overall change |
| the change in hip circumference | 16, 28, 40, 52 and 68 week visit as well as the overall change |
| the change in body mass index | 16, 28, 40, 52 and 68 week visit as well as the overall change |
| the change in coefficient of variation over 2 weeks (defined as 4-8 mmol/l), based on up to 2 weeks of Abbott Freestyle Libre ProTM sensor wear | from randomization until the 6, 16, 28 and 52 week visit |
| the change in interquartile range over 2 weeks (defined as 4-8 mmol/l), based on up to 2 weeks of Abbott Freestyle Libre ProTM sensor wear | from randomization until the 6, 16, 28 and 52 week visit |
| the change in time range over 2 weeks (defined as 4-8 mmol/l), based on up to 2 weeks of Abbott Freestyle Libre ProTM sensor wear | from randomization until the 6, 16, 28 and 52 week visit |
| Edmonton |
| Alberta |
| T6G 2E1 |
| Canada |
| Nova Scotia Health Authority | Halifax | Nova Scotia | B3H 1V7 | Canada |
| McMaster University | Hamilton | Ontario | Canada |
| St. Joseph's Hospital | London | Ontario | N6A 4V2 | Canada |
| Western University | London | Ontario | N6G 2M1 | Canada |
| LMC Manna Research | Oakville | Ontario | L6M 1M1 | Canada |
| The Ottawa Hospital | Ottawa | Ontario | K1Y 4E9 | Canada |
| D006946 | Hyperinsulinism |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |