Investigation of a switch from Insulin Therapy to a metformin & saxagliptin combination in patients with type 2 diabetes mellitus

• Conditions: Type 2 Diabetes mellitus; MedDRA version: 12.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

• Registration Number: EUCTR2009-016745-25-DE
• Lead Sponsor: ikfe GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-16
• Last Update Posted: 3 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 trial participation
- Experience ion self measurement of blood glucose <1 year

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 60ml/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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to show the effect of a switch from insulin therapy (BOT or ICT or CIT) to an oral therapy with saxagliptin & metformin over a period of six months in comparison to continuation of insulin therapy. Primary endpoint is the percentage of patients with stable HbA1c (no increase: delta < 0.5%) after switch. ;Secondary Objective: The secondary objectives are the impact of the switch on biomarkers of insulin resistance and ß-cell function, biomarkers of cardiovascular risk, patient treatment satisfaction, treatment costs, and requirement of 3rd line pioglitazone as rescue drug as well as on an oral glucose tolerance test (oGTT). Further the impact of the switch on the macrophage activation is a secondary objective in a subgroup at the site 01.;Primary end point(s): Primary endpoint is the percentage of patients with stable HbA1c after switch from insulin therapy (BOT or ICT or CIT) to an oral therapy with metformin & saxagliptin.