A study to learn more about how dapagliflozin affects body fat levels compared to glimepiride in patients with type 2 diabetes who are taking metformi
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0003600
- Lead Sponsor
- AstraZeneca Korea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 160
1 . Adults with T2DM(Type 2 diabetes mellitus) (Male or female, =19 and =75 years).
2 . Patients with insufficient glycaemic control (HbA1c =7.0% and <10.0% in recent 4 weeks).
3 . Patients with an unchanged dose of metformin (=1,000 mg/day) for =8 weeks prior to randomisation.
4 . Written informed consent.
5 . WOCBP(Women of child bearing potential) were to take precautions to avoid pregnancy throughout the study and for 4 weeks after intake of the last dose.
- WOCBP(Women of child bearing potential) had to have a negative urine pregnancy test at screening visit. Women of child bearing potential included any female who had experienced menarche and who had not undergone successful surgical sterilisation (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or was not postmenopausal.
- WOCBP(Women of child bearing potential) had to be willing to use a medically accepted method of contraception that was considered reliable in the judgment of the Investigator.
1 . Type 1 diabetes or history of diabetic ketoacidosis.
2 . Pregnant or breast-feeding patients.
3 . eGFR <60 mL/min/1.73 m2 (MDRD, Modification of Diet in Renal Disease) at Visit 1.
4 . Indication of active liver disease (AST(Aspartate aminotransferase)/ALT(Alanine aminotransferase)/total bilirubin >3 × upper limits of normal) at Visit 1.
5 . Acute coronary syndrome, stroke, or transient ischaemic attack within 3 months prior to randomisation
6 . Bariatric surgery within 2 years; treatment of anti-obesity drugs 3 months prior to randomisation; any treatment leading to unstable body weight. (Unstable body weight was considered reliable in the judgement of the Investigator.)
7. Any kind of surgery using foreign metallic materials.
8. History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time.
9. History of any other malignancy within 5 years (with the exception of successfully treated non-melanoma skin cancers)
10. History of alcohol or drug abuse judged by physician within 3 months prior to randomisation.
11. Concomitant participation in any other clinical study.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in total body fat mass from baseline using Dual Energy X-ray Absorptiometry (DXA) scan
- Secondary Outcome Measures
Name Time Method The change in HbA1c levels;The proportion of Subjects achieving a glycemic response, defined as HbA1c <7.0%;The change in Fasting blood sugar level(FBS) levels;Changes in body weight, waist circumference, Body mass index);Changes in systolic blood pressure(SBP) and diastolic blood pressure(DBP);Changes in abdominal visceral adipose tissue(VAT) and subcutaneous adipose tissue(SAT) volume, visceral adipose tissue(VAT)/subcutaneous adipose tissue(SAT) ratio using abdominal CT;Changes in lean mass from baseline using Dual Energy X-ray Absorptiometry (DXA) scan;Changes in high-sensitivity C-reactive protein (hsCRP) and adiponectin