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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Diabetes Mellitus, Type 2
Intervention	Drug: Metformin and Saxagliptin
Phase	Phase 4
Sponsor	ikfe-CRO GmbH
Responsible Party	ikfe-CRO GmbH
ClinicalTrials.gov Identifier	NCT01206647
First Received	September 15, 2010
Last Updated	September 21, 2010
Last verified	September 2010

Tracking Information[ + expand ][ + ]

First Received Date	September 15, 2010
Last Updated Date	September 21, 2010
Start Date	February 2010
Estimated Primary Completion Date	February 2011
Current Primary Outcome Measures	percentage of patients with stable HbA1c [Time Frame: 26 ± 2 weeks (baseline to postbaseline values) at 4 week intervals] [Designated as safety issue: No]
Current Secondary Outcome Measures	impact of the switch on: [Time Frame: 26 ± 2 weeks (baseline to postbaseline values)] [Designated as safety issue: No]- Biomarkers of insulin resistance and ß-cell function impact of the switch on: [Time Frame: 26 ± 2 weeks (baseline to postbaseline values)] [Designated as safety issue: No]- Biomarkers of cardiovaskular risk impact of the switch on: [Time Frame: 26 ± 2 weeks (baseline to postbaseline values)] [Designated as safety issue: No]- Patient treatment satifaction impact of the switch on: [Time Frame: 26 ± 2 weeks (baseline to postbaseline values)] [Designated as safety issue: No]- Treatment costs impact of the switch on: [Time Frame: 26 ± 2 weeks (baseline to postbaseline values)] [Designated as safety issue: No]- Requirement of 3rd line OAD pioglitazone as rescue drug impact of the switch on: [Time Frame: 26 ± 2 weeks (baseline to postbaseline values)] [Designated as safety issue: No]- oral Glucose Tolerance Test (oGTT) impact of the switch on: [Time Frame: 26 ± 2 weeks (baseline to postbaseline values)] [Designated as safety issue: No]- Macrophagen activation (in a subpopulation at site 01 ikfe GmbH)

Descriptive Information[ + expand ][ + ]

Brief Title	Investigation of a Switch From Insulin Therapy to a Metformin & Saxagliptin Combination in Patients With Type 2 Diabetes Mellitus
Official Title	Investigation of a Switch From Insulin Therapy to a Metformin & Saxagliptin Combination in Patients With Type 2 Diabetes Mellitus
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 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. 11:464-471, 2009). [2] Glimeperide is an agent with unspecific stimulating effect on the ß-cell and is considered to accelerate the progression of the disease while still controlling blood glucose. In addition, it may cause hypoglycemia. The combination of pioglitazone with glimepiride was selected, because pioglitazone requires approx. 5-6 weeks for developing its full anti-diabetic efficacy and an immediate effect on glucose was required to avoid glycemic deterioration. It is tempting to speculate that the combination of a drug providing ß-cell protection (like saxagliptin) with a drug effectively and rapidly lowering blood glucose through a different mechanism of action (metformin) instead of unspecific ß-cell stimulation would result in an even improved outcome without risk of hypoglycemia. 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.
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Diabetes Mellitus, Type 2
Intervention	Drug: Metformin and Saxagliptin Metformin 500mg/daily titrated to 2000mg/d in 4 Weeks (continued for 20 weeks) Saxagliptin 5 mg daily over complete trial
Study Arm (s)	No Intervention: Control arm The patients randomized to the control arm will continue their current therapy, as individually prescribed. Insulin will be administered via subcutaneous injection and OADs (if applicable) will be administered orally, as individually prescribed. Experimental: Saxagliptin & metformin Saxagliptin and metformin tablets will be administered orally. Pioglitazione (Rescue medication) tablets will be administered orally. Insulin glargine (Rescue medication) will be administered via subcutaneous injection as individually prescribed.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Active, not recruiting
Estimated Enrollment	120
Estimated Completion Date	February 2011
Estimated Primary Completion Date	February 2011
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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Germany

Administrative Information[ + expand ][ + ]

NCT Number	NCT01206647
Other Study ID Numbers	AZ-SAX-001
Has Data Monitoring Committee	No
Information Provided By	ikfe-CRO GmbH
Study Sponsor	ikfe-CRO GmbH
Collaborators	AstraZeneca IKFE Institute for Clinical Research and Development
Investigators	Principal Investigator: Andreas Pfützner, Prof.Dr.Dr. IKFE Institute for Clinical Research and Development
Verification Date	September 2010

Locations[ + expand ][ + ]

Diabetologische Schwerpunktpraxis Dr. Lorra / Dr. Bonnermann	Bochum, Germany, 44869
Zentrum für klinische Studien Dresden, GWT-TUD GmbH	Dresden, Germany, 01307
Gemeinschaftspraxis Partner der Gesundheit	Essen, Germany, 45355
IKFE Institute for Clinical Research and Development	Mainz, Germany, 55116
Zentrum für Diabetes und Gefäßerkrankungen	Münster, Germany, 48145
Diabetes Zentrum Neuwied	Neuwied, Germany, 56564
ikfe Studiencenter Potsdam GmbH	Potsdam, Germany, 14469