Dapagliflozin + Saxagliptin in a Basal-bolus Insulin Treatment

NCT02965443 | Terminated Phase 4 DMC

• 1 other identifier: UTUB - 2015-005740-34
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

To perform a study that investigates the effectiveness of adding the SGLT2 inhibitor dapagliflozin + the dipeptidyl peptidase 4 (DPP-4) inhibitor saxagliptin vs placebo to revert from a BBIT regimen to a BOT regimen in patients with type 2 diabetes.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects achieving a HbA1c ≤ 7.5% and having a reversal from a BBIT to a BOT regimen

  Percentage of subjects achieving a HbA1c ≤ 7.5% and having a reversal from a BBIT to a BOT regimen with treatment of dapagliflozin/saxagliptin or placebo

  24 weeks

Secondary Outcomes (14)

• changes in HbA1c between groups

  24 weeks

• changes in hypoglycaemic events between groups

  24 weeks

• changes in fasting blood glucose between groups

  24 weeks

• changes in daily insulin dose between groups

  24 weeks

• changes in bodyweight between groups

  24 weeks

Other Outcomes (9)

• changes in fetuin-A levels between groups

  24 weeks

• changes in adiponectin levels between groups

  24 weeks

• changes in (Interleucin 1?ßß) IL-1ß levels between groups

  24 weeks

Study Arms (2)

Verum

ACTIVE COMPARATOR

Dapagliflozin 10 mg + Saxagliptin 5 mg, each once daily, for 24 weeks

Drug: Dapagliflozin 10 mg + Saxagliptin 5 mg

Placebo

PLACEBO COMPARATOR

Placebo 1 10 mg + Placebo 2 5 mg, each once daily, for 24 weeks

Drug: Placebo 1 10 mg + Placebo 2 5 mg

Interventions

Dapagliflozin 10 mg + Saxagliptin 5 mg DRUG

24 weeks intervention with Dapagliflozin 10 mg + Saxagliptin 5 mg

Also known as: Forxiga + Onglyza

Verum

Placebo 1 10 mg + Placebo 2 5 mg DRUG

24 weeks intervention with Placebo 1 10 mg + Placebo 2 5 mg

Also known as: Placebo 1 + Placebo 2

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes
• Age 18 - 75 years
• Anti-GAD antibodies negative (Glutamic Acid Decarboxylase)
• C-peptide levels ≥ 1.5 ng/mL
• Fasting blood glucose \> 126 mg/dl
• HbA1c 8.0 - 10.5 %
• BMI 25.0 - 45.0 kg/m2
• Previous therapy with BBIT (basal insulin and at least once daily bolus insulin)

You may not qualify if:

• Use of any oral antidiabetic treatment except for metformin (i.e., sulphonylureas, DPP-IV inhibitors, thiazolidinediones, SGLT-2 inhibitors (Sodium dependent glucose transporter) or GLP-1 analogues (glucagone like peptide) within the last three months prior to Screening
• Repeated episodes of severe hypoglycaemia within the last six months prior to Screening
• History of diabetic ketoacidosis, precoma diabetica, or diabetic coma
• Treatment with any other investigational drug within the last three months before Screening
• Acute infections within the last four weeks prior to Screening
• Recurrent urogenital infections
• History of pancreatitis
• Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures
• History of severe or multiple allergies
• Concomitant participation in other clinical trials
• Type 1 diabetes
• Cardiovascular disease Clinically relevant ventricular tachycardia or ventricular fibrillation, 3rd degree AV block or Torsades de Pointes or treatment with antiarrhythmic drugs. Percutaneous coronary intervention within the past 6 months. Any of the following within the past 6 months: myocardial infarction (MI), coronary artery bypass surgery; unstable angina; or stroke.
• Uncontrolled unstable angina pectoris or history of pericarditis, myocarditis, endocarditis. Congestive heart failure NYHA (New York Heart Association) class III or IV. 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.
• Malignancy including leukemia and lymphoma within the last 5y.
• Liver disease such as cirrhosis or chronic active hepatitis.

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital Tübingen

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin; saxagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2016
• First Posted: November 16, 2016
• Study Start: February 2, 2018
• Primary Completion: February 3, 2020
• Study Completion: February 3, 2020
• Last Updated: February 11, 2020

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)