Status:
UNKNOWN
Investigation of a Switch From Insulin Therapy to a Metformin & Saxagliptin Combination in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
ikfe-CRO GmbH
Collaborating Sponsors:
AstraZeneca
IKFE Institute for Clinical Research and Development
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2011
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01206647
Start Date
February 1 2010
End Date
February 1 2011
Last Update
September 22 2010
Active Locations (7)
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1
Diabetologische Schwerpunktpraxis Dr. Lorra / Dr. Bonnermann
Bochum, Germany, 44869
2
Zentrum für klinische Studien Dresden, GWT-TUD GmbH
Dresden, Germany, 01307
3
Gemeinschaftspraxis Partner der Gesundheit
Essen, Germany, 45355
4
IKFE Institute for Clinical Research and Development
Mainz, Germany, 55116