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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT No 2008-000640-14 |
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The objective is to investigate the efficacy, safety and pharmacokinetics of three different doses of BI 10773 compared to placebo given for 12 weeks in patients with type 2 diabetes mellitus with insufficient glycemic control. In addition an open-label metformin arm will be assessed
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 10773 | Drug | |||
| placebo | Drug | |||
| metformin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Glycosilated Haemoglobin A1c (HbA1c) From Baseline After 12 Weeks of Treatment | Change of HbA1c from baseline after 12 weeks of treatment. Note, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of FPG From Baseline After 12 Weeks of Treatment | Change of Fasting Plasma Glucose (FPG) from baseline after 12 weeks of treatment. Results presented stem from a repeated measures analysis. Note, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1245.9.54001 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina | ||||
| 1245.9.54002 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35472672 | Derived | Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034. | |
| 23940010 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily. |
| FG001 | Empagliflozin 5 mg | Patients receive 5 mg Empagliflozin in tablets once daily. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline and 12 weeks |
| Change of HbA1c From Baseline Over Time | Change of HbA1c from baseline over time. Results presented stem from a repeated measures analysis. | Baseline and weeks 4, 8 and 12 |
| Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment | Results for HbA1c categories at week 12 (Proportion of patients with HbA1c less than equal to 7%). | 12 weeks |
| Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment | Results for HbA1c categories at week 12 (Proportion of patients with HbA1c lowered at least 0.5%). | 12 weeks |
| Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI) | Results for change of FPI from baseline at week 12 based on ANCOVA. | Baseline and 12 weeks |
| Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR) | HOMA-IR (to assess insulin resistance) is defined as (FPI x FPG)/22.5. Results based on ANCOVA. | Baseline and 12 weeks |
| Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B) | HOMA-%B (to assess insulin beta cell function) is defined as (20 x FPI)/(FPG-3.5). Results are based on ANCOVA. | Baseline and 12 weeks |
| Change of Body Weight After 12 Weeks of Treatment | Results for change of body weight after 12 weeks of treatment based on ANCOVA. | Baseline and 12 weeks |
| Trough Concentrations of Empagliflozin in Plasma | Pre-dose (within 30 minutes before dosing) trough concentrations of Empagliflozin in plasma | Days 28, 56 and 84 |
| Capital Federal |
| Argentina |
| 1245.9.54007 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina |
| 1245.9.54008 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina |
| 1245.9.54009 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina |
| 1245.9.54010 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina |
| 1245.9.54004 Boehringer Ingelheim Investigational Site | Mar del Plata | Argentina |
| 1245.9.54003 Boehringer Ingelheim Investigational Site | Mendoza | Argentina |
| 1245.9.54005 Boehringer Ingelheim Investigational Site | Salta | Argentina |
| 1245.9.54006 Boehringer Ingelheim Investigational Site | Salta | Argentina |
| 1245.9.38504 Boehringer Ingelheim Investigational Site | Karlovac | Croatia |
| 1245.9.38503 Boehringer Ingelheim Investigational Site | Krapinske Toplice | Croatia |
| 1245.9.38506 Boehringer Ingelheim Investigational Site | Osijek | Croatia |
| 1245.9.38505 Boehringer Ingelheim Investigational Site | Varaždin | Croatia |
| 1245.9.38501 Boehringer Ingelheim Investigational Site | Zagreb | Croatia |
| 1245.9.37201 Boehringer Ingelheim Investigational Site | Tallinn | Estonia |
| 1245.9.37202 Boehringer Ingelheim Investigational Site | Tallinn | Estonia |
| 1245.9.37203 Boehringer Ingelheim Investigational Site | Tallinn | Estonia |
| 1245.9.49007 Boehringer Ingelheim Investigational Site | Aschaffenburg | Germany |
| 1245.9.49001 Boehringer Ingelheim Investigational Site | Erlangen | Germany |
| 1245.9.49004 Boehringer Ingelheim Investigational Site | Hamburg | Germany |
| 1245.9.49005 Boehringer Ingelheim Investigational Site | Hamburg | Germany |
| 1245.9.49002 Boehringer Ingelheim Investigational Site | Melsungen | Germany |
| 1245.9.49008 Boehringer Ingelheim Investigational Site | Nuremberg | Germany |
| 1245.9.49003 Boehringer Ingelheim Investigational Site | Saint Ingbert/Oberwürzbach | Germany |
| 1245.9.49006 Boehringer Ingelheim Investigational Site | Sulzbach-Rosenberg | Germany |
| 1245.9.39006 Boehringer Ingelheim Investigational Site | Genova | Italy |
| 1245.9.39001 Boehringer Ingelheim Investigational Site | Pisa | Italy |
| 1245.9.39003 Boehringer Ingelheim Investigational Site | Pisa | Italy |
| 1245.9.39004 Boehringer Ingelheim Investigational Site | Siena | Italy |
| 1245.9.39005 Boehringer Ingelheim Investigational Site | Treviso | Italy |
| 1245.9.37002 Boehringer Ingelheim Investigational Site | Klaipėda | Lithuania |
| 1245.9.37001 Boehringer Ingelheim Investigational Site | Vilnius | Lithuania |
| 1245.9.40003 Boehringer Ingelheim Investigational Site | Brasov | Romania |
| 1245.9.40002 Boehringer Ingelheim Investigational Site | Bucharest | Romania |
| 1245.9.40004 Boehringer Ingelheim Investigational Site | Galati | Romania |
| 1245.9.40005 Boehringer Ingelheim Investigational Site | Târgu Mureş | Romania |
| 1245.9.70002 Boehringer Ingelheim Investigational Site | Kazan' | Russia |
| 1245.9.70003 Boehringer Ingelheim Investigational Site | Nizhny Novgorod | Russia |
| 1245.9.70004 Boehringer Ingelheim Investigational Site | Petrozavodsk | Russia |
| 1245.9.70005 Boehringer Ingelheim Investigational Site | Smolensk | Russia |
| 1245.9.70006 Boehringer Ingelheim Investigational Site | Yaroslavl | Russia |
| 1245.9.70007 Boehringer Ingelheim Investigational Site | Yaroslavl | Russia |
| 1245.9.70001 Boehringer Ingelheim Investigational Site | Yekaterinburg | Russia |
| 1245.9.62002 Boehringer Ingelheim Investigational Site | Bratislava | Slovakia |
| 1245.9.62003 Boehringer Ingelheim Investigational Site | Lučenec | Slovakia |
| 1245.9.62004 Boehringer Ingelheim Investigational Site | Nové Mesto nad Váhom | Slovakia |
| 1245.9.62001 Boehringer Ingelheim Investigational Site | Prievidza | Slovakia |
| 1245.9.82006 Boehringer Ingelheim Investigational Site | Goyang | South Korea |
| 1245.9.82008 Boehringer Ingelheim Investigational Site | Goyang | South Korea |
| 1245.9.82007 Boehringer Ingelheim Investigational Site | Incheon | South Korea |
| 1245.9.82002 Boehringer Ingelheim Investigational Site | Pucheon | South Korea |
| 1245.9.82001 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1245.9.82004 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1245.9.82005 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1245.9.82009 Boehringer Ingelheim Investigational Site | Suwon | South Korea |
| 1245.9.82003 Boehringer Ingelheim Investigational Site | Uijeongbu-si | South Korea |
| 1245.9.46003 Boehringer Ingelheim Investigational Site | Gothenburg | Sweden |
| 1245.9.46004 Boehringer Ingelheim Investigational Site | Härnösand | Sweden |
| 1245.9.46005 Boehringer Ingelheim Investigational Site | Lund | Sweden |
| 1245.9.46001 Boehringer Ingelheim Investigational Site | Stockholm | Sweden |
| 1245.9.46002 Boehringer Ingelheim Investigational Site | Västerås | Sweden |
| 1245.9.88605 Boehringer Ingelheim Investigational Site | Changhua | Taiwan |
| 1245.9.88607 Boehringer Ingelheim Investigational Site | Kaohsiung City | Taiwan |
| 1245.9.88604 Boehringer Ingelheim Investigational Site | Taichung | Taiwan |
| 1245.9.88606 Boehringer Ingelheim Investigational Site | Tainan | Taiwan |
| 1245.9.88601 Boehringer Ingelheim Investigational Site | Taipei | Taiwan |
| 1245.9.88603 Boehringer Ingelheim Investigational Site | Taipei | Taiwan |
| 1245.9.88602 Boehringer Ingelheim Investigational Site | Taoyuan | Taiwan |
| 1245.9.38003 Boehringer Ingelheim Investigational Site | Kharkiv | Ukraine |
| 1245.9.38004 Boehringer Ingelheim Investigational Site | Kiev | Ukraine |
| 1245.9.38002 Boehringer Ingelheim Investigational Site | Odesa | Ukraine |
| 1245.9.38001 Boehringer Ingelheim Investigational Site | Vinnytsia | Ukraine |
| 1245.9.38005 Boehringer Ingelheim Investigational Site | Vinnytsia | Ukraine |
| Riggs MM, Staab A, Seman L, MacGregor TR, Bergsma TT, Gastonguay MR, Macha S. Population pharmacokinetics of empagliflozin, a sodium glucose cotransporter 2 inhibitor, in patients with type 2 diabetes. J Clin Pharmacol. 2013 Oct;53(10):1028-38. doi: 10.1002/jcph.147. Epub 2013 Aug 13. |
| FG002 | Empagliflozin 10 mg | Patients receive 10 mg Empagliflozin in tablets once daily. |
| FG003 | Empagliflozin 25 mg | Patients receive 25 mg Empagliflozin in tablets once daily. |
| FG004 | Metformin OL | Patients were to take a open-label (OL) dose of 500 mg Metformin twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated. |
| COMPLETED |
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| NOT COMPLETED |
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The treated set (TS) consisting of all randomised patients who were treated with at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily. |
| BG001 | Empagliflozin 5 mg | Patients receive 5 mg Empagliflozin in tablets once daily. |
| BG002 | Empagliflozin 10 mg | Patients receive 10 mg Empagliflozin in tablets once daily. |
| BG003 | Empagliflozin 25 mg | Patients receive 25 mg Empagliflozin in tablets once daily. |
| BG004 | Metformin OL | Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Change of Glycosilated Haemoglobin A1c (HbA1c) From Baseline After 12 Weeks of Treatment | Change of HbA1c from baseline after 12 weeks of treatment. Note, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups. | The full analysis set (FAS) consists of all randomised patients who were treated with at least 1 dose of study drug and had a baseline measurement of the primary endpoint. Modified last observation carried forward was used as the imputation method (LOCF). | Posted | Mean | Standard Error | percentage of HbA1c | Baseline and 12 weeks |
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| Secondary | Change of FPG From Baseline After 12 Weeks of Treatment | Change of Fasting Plasma Glucose (FPG) from baseline after 12 weeks of treatment. Results presented stem from a repeated measures analysis. Note, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups. | FAS (LOCF) | Posted | Mean | Standard Error | mg/dL | Baseline and 12 weeks |
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| Secondary | Change of HbA1c From Baseline Over Time | Change of HbA1c from baseline over time. Results presented stem from a repeated measures analysis. | FAS, classical last observation carried forward (CLOCF) was used as the imputation method. | Posted | Mean | Standard Error | percentage of HbA1c | Baseline and weeks 4, 8 and 12 |
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| Secondary | Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment | Results for HbA1c categories at week 12 (Proportion of patients with HbA1c less than equal to 7%). | FAS (CLOCF) | Posted | Number | percentage of participants | 12 weeks |
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| Secondary | Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment | Results for HbA1c categories at week 12 (Proportion of patients with HbA1c lowered at least 0.5%). | FAS (CLOCF) | Posted | Number | percentage of participants | 12 weeks |
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| Secondary | Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI) | Results for change of FPI from baseline at week 12 based on ANCOVA. | FAS (CLOCF) | Posted | Mean | Standard Error | mU/L | Baseline and 12 weeks |
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| Secondary | Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR) | HOMA-IR (to assess insulin resistance) is defined as (FPI x FPG)/22.5. Results based on ANCOVA. | FAS (CLOCF) | Posted | Mean | Standard Error | mU/L x mmol/L | Baseline and 12 weeks |
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| Secondary | Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B) | HOMA-%B (to assess insulin beta cell function) is defined as (20 x FPI)/(FPG-3.5). Results are based on ANCOVA. | FAS (CLOCF) | Posted | Mean | Standard Error | mU / mmol | Baseline and 12 weeks |
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| Secondary | Change of Body Weight After 12 Weeks of Treatment | Results for change of body weight after 12 weeks of treatment based on ANCOVA. | FAS (CLOCF) | Posted | Mean | Standard Error | kg | Baseline and 12 weeks |
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| Secondary | Trough Concentrations of Empagliflozin in Plasma | Pre-dose (within 30 minutes before dosing) trough concentrations of Empagliflozin in plasma | All patients who received at least one dose of Empagliflozin and have some Pharmacokinetic (PK) data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | Days 28, 56 and 84 |
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From first drug administration until 7 days after last intake of study medication, up to 121 days
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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 | Placebo | Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily. | 0 | 82 | 1 | 82 | ||
| EG001 | Empagliflozin 5 mg | Patients receive 5 mg Empagliflozin in tablets once daily. | 2 | 81 | 3 | 81 | ||
| EG002 | Empagliflozin 10 mg qd | Patients receive 10 mg Empagliflozin in tablets once daily. | 0 | 81 | 5 | 81 | ||
| EG003 | Empagliflozin 25 mg qd | Patients receive 25 mg Empagliflozin in tablets once daily. | 1 | 82 | 1 | 82 | ||
| EG004 | Metformin OL | Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated. | 3 | 80 | 7 | 80 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MEDDRA 12.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MEDDRA 12.0 | Systematic Assessment |
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| Prinzmetal angina | Cardiac disorders | MEDDRA 12.0 | Systematic Assessment |
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| Intestinal functional disorder | Gastrointestinal disorders | MEDDRA 12.0 | Systematic Assessment |
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| Hand fracture | Injury, poisoning and procedural complications | MEDDRA 12.0 | Systematic Assessment |
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| Ligament rupture | Injury, poisoning and procedural complications | MEDDRA 12.0 | Systematic Assessment |
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| Meniscus lesion | Injury, poisoning and procedural complications | MEDDRA 12.0 | Systematic Assessment |
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| Pelvic fracture | Injury, poisoning and procedural complications | MEDDRA 12.0 | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MEDDRA 12.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MEDDRA 12.0 | Systematic Assessment |
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| Thirst | General disorders | MEDDRA 12.0 | Systematic Assessment |
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Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Male |
|
| ANCOVA | Based on ANCOVA with terms for baseline, treatment, number of previous anti-diabetic medications and country. | <0.0001 | No formal testing so adjustment for multiple comparisons was not necessary. | Mean Difference (Final Values) | -0.57 | Standard Error of the Mean | 0.11 | 2-Sided | 95 | -0.80 | -0.35 | Difference calculated as empa 10mg minus placebo | No | Superiority or Other |
| ANCOVA | Based on ANCOVA with terms for baseline, treatment, number of previous anti-diabetic medications and country. | <0.0001 | No formal testing so adjustment for multiple comparisons was not necessary. | Mean Difference (Final Values) | -0.72 | Standard Error of the Mean | 0.11 | 2-Sided | 95 | -0.94 | -0.50 | Difference calculated as empa 25mg minus placebo | No | Superiority or Other |
| OG004 | Metformin OL | Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated. |
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Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
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Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
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Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
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