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Low recruitment rate and an inability to meet power.
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A randomized study of continuing versus holding metformin during hospitalizations to internal medicine services to determine the effects on glucose control, acidosis, abdominal symptoms, length of stay, and mortality.
The purpose of this study is to determine what the effects of the routine practice of holding metformin in hospitalized patients with type 2 diabetes are on outcomes.
The objectives of this study are to determine how holding versus continuing metformin during hospitalization to an internal medicine service affects the incidences of lactic acidosis, mean anion gap, mean glucose levels, low and very high blood sugars, GI effects after discharge, lack of continuation of metformin upon discharge, mean glucose levels, lengths of stay, and 30-day mortality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin continuation | Active Comparator | Continuation of home metformin regimen during hospitalization to an internal medicine service |
|
| Metformin discontinuation | No Intervention | Holding home metformin regimen during hospitalization to an internal medicine service |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Continuation of home metformin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean glucose levels | Average of daily glucose levels during hospitalization | During hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hyperglycemia greater than 300 mg/dl. | Glucose > 300 | During hospitalization |
| Incidence of hypoglycemia (Glu = 54 - 70). | Glu = 54 - 70 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean glucose levels while receiving metformin in the continuation arm and while not receiving metformin in the discontinuation arm | Mean daily glucose levels will only be included for the days in which the subjects received or did not receive metformin as per their assigned arm. | During hospitalization |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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Randomized, parallel, prospective trial.
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| During hospitalization |
| Incidence of moderate hypoglycemia (Glu < 54) | Glu < 54 | During hospitalization |
| Incidence of severe hypoglycemia (Glu < 54 with symptoms) | Glu < 54 with symptoms | During hospitalization |
| Mean lactic acid levels. | Mean lactic acid levels | During hospitalization |
| Incidence of lactic acid levels greater than 2.0. | Lactic acid > 2.0 | During hospitalization |
| Mean anion gap. | Mean anion gap, a calculated value | During hospitalization |
| Incidence of anion gap > 11 | Anion Gap > 11 | During hospitalization |
| Incidence of elevated lactic acid level or anion gap. | Lactic acid > 2.0 or Anion Gap > 11 | During hospitalization |
| Incidence of inadvertently not continuing metformin on discharge | Transitions of care | At discharge |
| GI adverse effects | GI side effects after discharge | Within 3 days of discharge |
| Mortality | Mortality as determined via chart search and follow up phone call | 30 +/- 3 days after discharge |
| D004700 | Endocrine System Diseases |