Investigation of a Switch From Insulin Therapy to a Metformin & Saxagliptin Combination in Patients With Type 2 Diabetes Mellitus

• Status: Unknown status
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the success rate of a switch from insulin therapy to a metformin & saxagliptin combination in patients with type 2 diabetes mellitus.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ikfe-CRO GmbH
• Collaborators: AstraZeneca; IKFE Institute for Clinical Research and Development
• Treatments: Insulin; Insulin, Globin Zinc; Metformin; Saxagliptin

Criteria

Inclusion Criteria:

• Combination of OAD and basal insulin treatment (BOT) or intensified conventional therapy (ICT; > 2 injections of basal and prandial) or conventional insulin therapy (CIT; 1 or 2 injections of basal or biphasic)

• HbA1c < 7.5 %

• Age: 18-80 years inclusively

• Duration of insulin therapy > 1 year

• Insulin dose < 120 IU/day

• Fasting C-peptide > 0.6 ng/l

• Fasting glucose ≤ 210 mg/dl

• Full legal, mental and physical ability to give informed consent

• Patient consent that the general physician will be informed of trail participation

• Experience in self measurement of blood glucose > 1 year

Exclusion Criteria:

• Type 1 Diabetes mellitus

• History of drug or alcohol abuse within the last five years prior to screening

• History of severe or multiple allergies

• Progressive fatal disease

• History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), neurological, psychiatric and/or haematological disease as judged by the investigator

• Renal insufficiency or history of significant renal diseases (creatinine clearance lower than 60 ml/min determined using the Cockroft-Goult equation).

• Contra-indications for study drugs including contraindications for the rescue drugs

• Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures

• Pregnancy or breast feeding

• Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomised partner

• Treatment with any other investigational drug within 3 months prior to screening

• Lack of compliance or other similar reason, that according to investigator, precludes satisfactory participation in the study