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| ID | Type | Description | Link |
|---|---|---|---|
| Control # 139433, 143584 | Other Identifier | Health Canada | |
| 10-346 | Other Identifier | Hamilton Health Sciences Research Ethics Board |
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| Name | Class |
|---|---|
| Hamilton Health Sciences Corporation | OTHER |
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The purpose of this pilot trial is to determine whether an intensive treatment with insulin glargine, metformin, acarbose and lifestyle can normalize blood glucose levels in patients with recently diagnosed type 2 diabetes mellitus when compared to standard diabetes care.
This is a pilot trial of 125 patients allocated to either usual care (1/3), 2 months or 4 months of intensive lifestyle and pharmacotherapy followed by cessation of all drug therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (short) | Experimental |
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| Group 2 (long) | Experimental |
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| Standard care | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin glargine | Drug | sc injection |
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| metformin |
| Measure | Description | Time Frame |
|---|---|---|
| Normoglycemia on Therapy |
Normoglycemia on therapy is defined as a mean fasting capillary blood glucose \ | (1) 8 weeks and (2) 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 1) Percentage of Participants With Normal Glucose Tolerance in the Experimental Group 1 Compared to the Control Group. 2) Percentage of Participants With Normal Glucose Tolerance in the Experimental Group 2 Compared to the Control Group. | Normal glucose tolerance is defined as a fasting plasma glucose <6.1 mmol/L and a 2-hour pc plasma glucose <7.8 mmol/L on a 75 g oral glucose tolerance test off diabetes drugs. |
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Inclusion Criteria:
Exclusion Criteria:
current use of insulin therapy
history of hypoglycemia unawareness, or severe hypoglycemia requiring assistance
renal dysfunction as evidenced by serum creatinine (Cr) ≥ 124 μmol/l
history of lactic acidosis or diabetic ketoacidosis
active liver disease or elevated alanine transferase (ALT) levels ≥ 2.5 times upper limit of normal at the time of enrollment
history of inflammatory bowel disease, colonic ulcers, recent or significant bowel surgery, or predisposition to bowel obstruction
cardiovascular disease including any of:
pulmonary disease with dependence on oxygen
history of any disease requiring intermittent or continuous systemic glucocorticoid treatment
history of any major illness with a life expectancy of <3 years
history of injury or any other condition that significantly limits participant's ability to achieve moderate levels of physical activity
any history of excessive alcohol intake, acute or chronic
known hypersensitivity to metformin, acarbose, or insulin glargine.
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| Name | Affiliation | Role |
|---|---|---|
| Hertzel Gerstein, MD | Population Health Research Institute | Principal Investigator |
| Natalia McInnes (nee Yakubovich), MD | Population Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University Medical Centre, Diabetes Care and Research Program | Hamilton | Ontario | L8N 3Z5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28324049 | Result | McInnes N, Smith A, Otto R, Vandermey J, Punthakee Z, Sherifali D, Balasubramanian K, Hall S, Gerstein HC. Piloting a Remission Strategy in Type 2 Diabetes: Results of a Randomized Controlled Trial. J Clin Endocrinol Metab. 2017 May 1;102(5):1596-1605. doi: 10.1210/jc.2016-3373. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 (Short) | insulin glargine: sc injection metformin: oral administration acarbose: oral administration lifestyle therapy: diet and exercise |
| FG001 | Group 2 (Long) | insulin glargine: sc injection metformin: oral administration acarbose: oral administration lifestyle therapy: diet and exercise |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
oral administration |
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| acarbose | Drug | oral administration |
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| lifestyle therapy | Behavioral | diet and exercise |
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| insulin glargine | Drug | sc injection |
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| metformin | Drug | oral administration |
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| acarbose | Drug | oral administration |
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| lifestyle therapy | Behavioral | diet and exercise |
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| Standard glycemic care | Other | as informed by the current clinical practice guidelines |
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| (1) 20 weeks and (2) 28 weeks |
| Percentage of Participants With Normal Fasting Plasma Glucose | Normal fasting plasma glucose is defined as <6.1 mmol/L. | 52 weeks |
| Change in Fasting Plasma Glucose From Baseline | Baseline and 52 weeks |
| HbA1C | 8, 20, 28 and 52 weeks |
| Change in Weight From Baseline | Baseline, 8, 20, 28 and 52 weeks |
| Number of Participants With Symptomatic Hypoglycemic Episodes | 52 weeks |
| Number of Participants With Severe Hypoglycemic Episodes | 52 weeks |
| FG002 | Standard Care | Standard glycemic care: as informed by the current clinical practice guidelines |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 (Short) | insulin glargine: sc injection metformin: oral administration acarbose: oral administration lifestyle therapy: diet and exercise |
| BG001 | Group 2 (Long) | insulin glargine: sc injection metformin: oral administration acarbose: oral administration lifestyle therapy: diet and exercise |
| BG002 | Standard Care | Standard glycemic care: as informed by the current clinical practice guidelines |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Normoglycemia on Therapy |
Normoglycemia on therapy is defined as a mean fasting capillary blood glucose \ | Primary outcome (1) is reported in Experimental Group 1 and Standard care at 8 weeks. Primary outcome (2) is reported in experimental Group 2 and Standard care at 16 weeks. | Posted | Count of Participants | Participants | (1) 8 weeks and (2) 16 weeks |
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| Secondary | 1) Percentage of Participants With Normal Glucose Tolerance in the Experimental Group 1 Compared to the Control Group. 2) Percentage of Participants With Normal Glucose Tolerance in the Experimental Group 2 Compared to the Control Group. | Normal glucose tolerance is defined as a fasting plasma glucose <6.1 mmol/L and a 2-hour pc plasma glucose <7.8 mmol/L on a 75 g oral glucose tolerance test off diabetes drugs. | Outcome (1) is reported in Experimental Group 1 and Standard care at 20 weeks. Outcome (2) is reported in experimental Group 2 and Standard care at 28 weeks. | Posted | Count of Participants | Participants | (1) 20 weeks and (2) 28 weeks |
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| Secondary | Percentage of Participants With Normal Fasting Plasma Glucose | Normal fasting plasma glucose is defined as <6.1 mmol/L. | Posted | Count of Participants | Participants | 52 weeks |
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| Secondary | Change in Fasting Plasma Glucose From Baseline | FPG was not available for some participants at 52 weeks. | Posted | Mean | Standard Deviation | mmol/L | Baseline and 52 weeks |
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| Secondary | HbA1C | Some participants did not provide HbA1C values. | Posted | Mean | Standard Deviation | percent | 8, 20, 28 and 52 weeks |
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| Secondary | Change in Weight From Baseline | Posted | Mean | Standard Deviation | kg | Baseline, 8, 20, 28 and 52 weeks |
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| Secondary | Number of Participants With Symptomatic Hypoglycemic Episodes | Posted | Count of Participants | Participants | 52 weeks |
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| Secondary | Number of Participants With Severe Hypoglycemic Episodes | Posted | Count of Participants | Participants | 52 weeks |
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52 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 (Short) | insulin glargine: sc injection metformin: oral administration acarbose: oral administration lifestyle therapy: diet and exercise | 0 | 28 | 0 | 28 | 3 | 28 |
| EG001 | Group 2 (Long) | insulin glargine: sc injection metformin: oral administration acarbose: oral administration lifestyle therapy: diet and exercise | 0 | 27 | 0 | 27 | 1 | 27 |
| EG002 | Standard Care | Standard glycemic care: as informed by the current clinical practice guidelines | 0 | 28 | 0 | 28 | 3 | 28 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders | Non-systematic Assessment |
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| Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Motor vehicle accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Natalia McInnes (nee Yakubovich) | McMaster University | 905-521-2100 | natalia.mcinnes@mcmaster.ca |
| 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 |
| D006946 | Hyperinsulinism |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| D008687 | Metformin |
| D020909 | Acarbose |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| 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 |
| D014312 | Trisaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Male |
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| Non-Caucasian |
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| Group 2 and Standard care at 16 weeks |
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| Units | Counts |
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| Participants |
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