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

Launched by IKFE-CRO GMBH · Sep 21, 2010

Keywords

ClinConnect Summary

The following study is based on a previous clinical trial performed at ikfe GmbH in Mainz in 2006 and 2007 (PIOswitch). \[2\] The purpose of this trial was to demonstrate that type 2 diabetes patients treated with insulin can be effectively switched to a pioglitazone/glimepiride combination without loss of glycemic control. The study was performed with 100 patients, out of whom 76 were finally successfully switched, resulting in a cheaper and more convenient therapy with indications of an improved laboratory cardiovascular risk biomarker profile (Hohberg et al., Diabetes Obes. Metab. 11:464...

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Eligibility 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