Investigation of a Switch From Insulin Therapy to a Metformin & Saxagliptin Combination in Patients With Type 2 Diabetes Mellitus
Recruitment status was Active, not recruiting
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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 | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: Metformin and Saxagliptin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Investigation of a Switch From Insulin Therapy to a Metformin & Saxagliptin Combination in Patients With Type 2 Diabetes Mellitus |
- percentage of patients with stable HbA1c [ Time Frame: 26 ± 2 weeks (baseline to postbaseline values) at 4 week intervals ] [ Designated as safety issue: No ]
- 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)
| Estimated Enrollment: | 120 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | February 2011 |
| Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Germany | |
| 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 | |
| Principal Investigator: | Andreas Pfützner, Prof.Dr.Dr. | IKFE Institute for Clinical Research and Development |
More Information
No publications provided
| Responsible Party: | Prof. Andreas Pfuetzner, IKFE Institute for Clinical Research and Development |
| ClinicalTrials.gov Identifier: | NCT01206647 History of Changes |
| Other Study ID Numbers: | AZ-SAX-001 |
| Study First Received: | September 15, 2010 |
| Last Updated: | September 21, 2010 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Saxagliptin Insulin Metformin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013