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| Name | Class |
|---|---|
| Sanofi | 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 iGlarLixi, 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 12-week course of treatment with iGlarLixi, metformin and lifestyle therapy, and (b) standard diabetes therapy, and followed for a total of 64 weeks (1 year and 3 months). In all participants with HbA1C<7.3% at the 12 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: iGlarLixi - sc injection; Drug: metformin - oral administration; Drug: insulin glargine - 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 |
|---|---|---|---|---|
| iGlarLixi | Drug | Dose is titrated to achieve fasting normoglycemia |
|
| Measure | Description | Time Frame |
|---|---|---|
| The first occurrence of diabetes relapse | 64 weeks of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants achieving drug-free diabetes remission | Diabetes remission is defined as HbA1C < 6.5% off diabetes drugs for at least 12 weeks | 24 weeks after randomization |
| Number of participants achieving drug-free normoglycemia defined as HbA1C < 6.0% off diabetes drugs for at least 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natalia McInnes, MD | McMaster University | Principal Investigator |
| Hertzel Gerstein, MD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2T 5C7 | Canada | ||
| LMC |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| C479460 | lixisenatide |
| D008687 | Metformin |
| D004032 | Diet |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Insulin Glargine | Drug | In those who need additional insulin or who cannot tolerate iGlarLixi, insulin glargine will be used. Dose is titrated to achieve fasting normoglycemia. |
|
|
| Metformin | Drug | Dose is titrated to 2000 mg daily or maximal tolerated dose |
|
| Lifestyle therapy | Behavioral | Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving |
|
|
| 24 weeks after randomization |
| Percentage of weight loss from baseline | (Weight at randomization - weight at 12 weeks)/(weight at randomization) | 12 weeks |
| Change in waist circumference from baseline | (Waist circumference at 12 weeks - weight circumference at randomization) | 12 weeks |
| Glycated hemoglobin (HbA1C) | Expressed in Diabetes Control and Complications Trial (DCCT) units | 12 weeks |
| Burlington |
| Ontario |
| M4G 3E8 |
| Canada |
| Joanne Liutkus | Cambridge | Ontario | N1R 7L6 | Canada |
| McMaster University | Hamilton | Ontario | L8N 3Z5 | Canada |
| St. Joseph's Hospital | London | Ontario | N6A 4V2 | Canada |
| Western University | London | Ontario | N6G 2M1 | Canada |
| The Ottawa Hospital | Ottawa | Ontario | K1Y 4E9 | Canada |
| McGill University | Montreal | Quebec | H4A 3J1 | Canada |
| D006946 | Hyperinsulinism |
| D001519 | Behavior |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D009747 | 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 |