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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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This study is being carried out to see if dapagliflozin in addition to metformin decreases body weight and if so, how it compares with metformin alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Dapagliflozin 10 mg plus Metformin |
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| B | Placebo Comparator | Placebo plus Metformin |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | Tablet oral 10 mg total daily dose once daily 102 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change in Total Body Weight | To evaluate the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin on total body weight after 24 weeks of oral administration of double-blind treatment. | Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change in Waist Circumference | To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on waist circumference. | Baseline to Week 24 |
| Adjusted Mean Change in Body Fat Mass |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-4) | To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at lumbar spine (L1-4) as measured by Dual Energy X-ray Absorptiometry. | Baseline to Week 102 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Bolinder, MD, PhD | Dept of Endocrinology, Metabolism and Diabetes Karolinska University Hospital Huddinge Karolinska Institutet 141 86 Stockholm Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Blagoevgrad | Bulgaria | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38770818 | Derived | Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2. | |
| 26894924 |
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During a placebo lead-in period, participants were counselled on dietary and life-style modifications. The metformin dose was adjusted to open label 1500 mg/day, 2000 mg/day or 2500 mg/day. Neither gender should exceed 60% of the total number of randomized participants.
First participant enrolled: 13 Feb 2009. Last participant completed 24 week period: 03 Jun 2010. 314 participants were enrolled, 182 were randomized in 40 centers in 5 European countries. Men aged 30-75 years and women aged 55-75 years with inadequate glycemic control (HbA1c 6.5% to 8.5%), BMI of at least 25 kg/sqm and body weight <= 120 kg.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Plus Metformin | Placebo oral once daily plus metformin over 24 weeks |
| FG001 | Dapagliflozin Plus Metformin | Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Metformin |
| Drug |
Tablet oral 1500 - 2500 mg total daily dose 1-3 times a day104 weeks |
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| Sitagliptin | Drug | Tablet oral 100 mg total daily dose once daily rescue medication |
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| Placebo | Drug | Matching placebo for dapagliflozin, tablet, oral, once daily, 102 weeks |
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To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on total body fat mass measured by dual energy X-ray absorptiometry. |
| Baseline to Week 24 |
| Proportion of Participants With Body Weight Decrease ≥5% | To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on body weight decrease ≥5%. Least Squares Mean represents the percent of participants adjusted for body weight baseline value. | Baseline to Week 24 |
| Adjusted Percent Change in Bone Mineral Density (BMD) at Femoral Neck | To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at femoral neck as measured by Dual Energy X-ray Absorptiometry. | Baseline to Week 102 |
| Adjusted Percent Change in Bone Mineral Density (BMD) at Total Hip | To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at total hip as measured by Dual Energy X-ray Absorptiometry. | Baseline to Week 102 |
| Sofia |
| Bulgaria |
| Research Site | Beroun | Czechia |
| Research Site | Brno | Czechia |
| Research Site | Prague | Czechia |
| Research Site | Semily | Czechia |
| Research Site | Slaný | Czechia |
| Research Site | Balatonfüred | Hungary |
| Research Site | Budapest | Hungary |
| Research Site | Csongrád | Hungary |
| Research Site | Kecskemét | Hungary |
| Research Site | Tát | Hungary |
| Research Site | Elblag | Poland |
| Research Site | Krakow | Poland |
| Research Site | Torun | Poland |
| Research Site | Gothenburg | Sweden |
| Research Site | Jarfalla | Sweden |
| Research Site | Lund | Sweden |
| Research Site | Malmö | Sweden |
| Research Site | Stockholm | Sweden |
| Research Site | Uppsala | Sweden |
| Kohan DE, Fioretto P, Johnsson K, Parikh S, Ptaszynska A, Ying L. The effect of dapagliflozin on renal function in patients with type 2 diabetes. J Nephrol. 2016 Jun;29(3):391-400. doi: 10.1007/s40620-016-0261-1. Epub 2016 Feb 19. |
| 23906445 | Derived | Bolinder J, Ljunggren O, Johansson L, Wilding J, Langkilde AM, Sjostrom CD, Sugg J, Parikh S. Dapagliflozin maintains glycaemic control while reducing weight and body fat mass over 2 years in patients with type 2 diabetes mellitus inadequately controlled on metformin. Diabetes Obes Metab. 2014 Feb;16(2):159-69. doi: 10.1111/dom.12189. Epub 2013 Aug 29. |
| 22651373 | Derived | Ljunggren O, Bolinder J, Johansson L, Wilding J, Langkilde AM, Sjostrom CD, Sugg J, Parikh S. Dapagliflozin has no effect on markers of bone formation and resorption or bone mineral density in patients with inadequately controlled type 2 diabetes mellitus on metformin. Diabetes Obes Metab. 2012 Nov;14(11):990-9. doi: 10.1111/j.1463-1326.2012.01630.x. Epub 2012 Jun 29. |
| COMPLETED |
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| NOT COMPLETED |
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Full Analysis Set defined as all randomized participants (as randomized) who received at least one dose of double-blind study medication, who have a non-missing baseline value and at least one post-baseline efficacy value for at least one efficacy variable during double-blind treatment period.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Plus Metformin | Placebo oral once daily plus metformin over 24 weeks |
| BG001 | Dapagliflozin Plus Metformin | Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks |
| BG002 | 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 | Number | Participants |
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| Body Weight | Mean | Standard Deviation | Kilogram |
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| Body Mass Index | Mean | Standard Deviation | kg/m2 |
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| Glycosylated hemoglobin A1c (HbA1c) | Mean | Standard Deviation | Percent |
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| Fasting Plasma Glucose | Mean | Standard Deviation | Milligram per deciliter |
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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 | Adjusted Mean Change in Total Body Weight | To evaluate the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin on total body weight after 24 weeks of oral administration of double-blind treatment. | Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values | Posted | Least Squares Mean | 95% Confidence Interval | kg | Baseline to Week 24 |
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| Secondary | Adjusted Mean Change in Waist Circumference | To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on waist circumference. | Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values | Posted | Least Squares Mean | 95% Confidence Interval | cm | Baseline to Week 24 |
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| Secondary | Adjusted Mean Change in Body Fat Mass | To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on total body fat mass measured by dual energy X-ray absorptiometry. | Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values | Posted | Least Squares Mean | 95% Confidence Interval | kg | Baseline to Week 24 |
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| Secondary | Proportion of Participants With Body Weight Decrease ≥5% | To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on body weight decrease ≥5%. Least Squares Mean represents the percent of participants adjusted for body weight baseline value. | Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of participants | Baseline to Week 24 |
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| Other Pre-specified | Adjusted Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-4) | To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at lumbar spine (L1-4) as measured by Dual Energy X-ray Absorptiometry. | Safety Analysis Set (all participants who received at least one dose of double-blind study medication) | Posted | Least Squares Mean | 95% Confidence Interval | Percent | Baseline to Week 102 |
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| Other Pre-specified | Adjusted Percent Change in Bone Mineral Density (BMD) at Femoral Neck | To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at femoral neck as measured by Dual Energy X-ray Absorptiometry. | Safety Analysis Set (all participants who received at least one dose of double-blind study medication) | Posted | Least Squares Mean | 95% Confidence Interval | Percent | Baseline to Week 102 |
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| Other Pre-specified | Adjusted Percent Change in Bone Mineral Density (BMD) at Total Hip | To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at total hip as measured by Dual Energy X-ray Absorptiometry. | Safety Analysis Set (all participants who received at least one dose of double-blind study medication) | Posted | Least Squares Mean | 95% Confidence Interval | Percent | Baseline to Week 102 |
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Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 24-week double-blind treatment plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
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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 Plus Metformin | Placebo oral once daily plus metformin over 24 weeks | 1 | 91 | 9 | 91 | ||
| EG001 | Dapagliflozin Plus Metformin | Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks | 6 | 91 | 7 | 91 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Oesophageal varices hemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Transient ischemic attack | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
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| Ulcerative keratitis | Eye disorders | MedDRA 13.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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For participants who did not complete 24 weeks, last observation carried forward (LOCF) was used.
If an Investigator requests permission to publish data from this study any such publication is to be agreed with AstraZeneca (AZ) in advance. The investigator agrees to provide AZ as soon as possible with drafts of proposed publications. Unless otherwise agreed, AZ shall have a period of 60 days from receipt of the proposed final manuscript to review it and may within such time require that submission for publication of the manuscript be delayed in order for AZ to file patent applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eva Johnsson | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| D008687 | Metformin |
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
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| Male |
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