Status:
COMPLETED
Saxagliptin in Combination With Dapagliflozin - Effects on Islet Cell Function
Lead Sponsor:
Prof. Dr. Thomas Forst
Conditions:
Type2 Diabetes Mellitus
Eligibility:
All Genders
30-75 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate alpha- and beta-cell function during combination treatment with saxagliptin in addition to dapagliflozin and metformin compared to placebo in addition to dapag...
Detailed Description
List of Abbreviations AE Adverse event ALT Alanine aminotransferase ANOVA Analysis of variance APTT Activated partial thromboplastin time AST Aspartate aminotransferase AUCins Area under the serum ins...
Eligibility Criteria
Inclusion
- Diabetes mellitus type 2 for at least three months prior to Screening
- HbA1c 7.0%-9.9%, both inclusive
- Treatment with metformin (daily dose 1500 - 3000 mg)
- Age 30-75 years, both inclusive
- BMI 25-35 kg/m\^2, both inclusive
Exclusion
- Use of any oral antidiabetic treatment except for metformin (i.e., sulphonylureas, DPP-IV inhibitors, thiazolidinediones, SGLT-2 inhibitors) within the last three months prior to Screening
- Use of insulin or GLP-1 analogues within three months prior to Screening
- Treatment with any other investigational drug within three months before screening
- History of diabetes mellitus type 1
- Acute infections within the last two weeks prior to Screening
- Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures
- History of severe or multiple allergies
- GFR (as calculated by the Cockroft-Gault equation) \< 60 ml/min at Screening
- State after kidney transplantation
- Laboratory safety value(s) outside the reference range and deemed clinically relevant by the Investigator
- Sexually active woman of childbearing age not practicing a highly effective method of birth control as defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, sexual abstinence or vasectomised partner
- Pregnancy or breast feeding
- Systolic blood pressure outside the range of 100-160 mmHg or diastolic blood pressure above 90 mmHg at Screening
- Acute myocardial infarction or cerebral event (stroke/TIA) within six months prior to Screening
- Uncontrolled unstable angina pectoris or history of pericarditis, myocarditis, endocarditis
- Increased risk of thromboembolism, e.g. subjects with a history of deep leg vein thrombosis or family history of deep leg vein thrombosis, as judged by the Investigator
- Hemodynamic relevant aortic stenosis, Aortic aneurysm
- Repeated episodes of severe hypoglycaemia within six months prior to Screening
- History of diabetic ketoacidosis, praecoma diabeticum, or diabetic coma
- Recurrent urogenital infections
- Haematuria
- History of pancreatitis
- Progressive fatal disease
- Elective surgery planned during study participation
- Acute or scheduled investigation with iodine containing radiopaque material
- History of drug or alcohol abuse in the past two years
- Donation of blood, major blood loss (\>=500 ml), or major surgery within the last three months prior to Screening
- Active hepatitis B, measured by positive tests of surface antigen HBsAg and/or active hepatitis C, measured by positive hepatitis C virus antibody tests (HCV) at Screening
- Positive human immunodeficiency virus (HIV) antibodies or HIV 1 Ag at Screening
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT02304081
Start Date
January 1 2015
End Date
August 1 2016
Last Update
June 20 2018
Active Locations (1)
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1
Profil Mainz GmbH & Co. KG
Mainz, Germany, 55116