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

NCT ID: NCT01206647

Last Updated: 2010-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-02-28

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Metformin and Saxagliptin

Intervention Type DRUG

Metformin 500mg/daily titrated to 2000mg/d in 4 Weeks (continued for 20 weeks) Saxagliptin 5 mg daily over complete trial

Interventions

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Metformin and Saxagliptin

Metformin 500mg/daily titrated to 2000mg/d in 4 Weeks (continued for 20 weeks) Saxagliptin 5 mg daily over complete trial

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

IKFE Institute for Clinical Research and Development

OTHER

Sponsor Role collaborator

ikfe-CRO GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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IKFE Institute for Clinical Research and Development

Principal Investigators

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Andreas Pfützner, Prof.Dr.Dr.

Role: PRINCIPAL_INVESTIGATOR

IKFE Institute for Clinical Research and Development

Locations

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Diabetologische Schwerpunktpraxis Dr. Lorra / Dr. Bonnermann

Bochum, , Germany

Site Status

Zentrum für klinische Studien Dresden, GWT-TUD GmbH

Dresden, , Germany

Site Status

Gemeinschaftspraxis Partner der Gesundheit

Essen, , Germany

Site Status

IKFE Institute for Clinical Research and Development

Mainz, , Germany

Site Status

Zentrum für Diabetes und Gefäßerkrankungen

Münster, , Germany

Site Status

Diabetes Zentrum Neuwied

Neuwied, , Germany

Site Status

ikfe Studiencenter Potsdam GmbH

Potsdam, , Germany

Site Status

Countries

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Germany

Other Identifiers

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AZ-SAX-001

Identifier Type: -

Identifier Source: org_study_id