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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Unknown status

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Metformin and Saxagliptin

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Diabetologische Schwerpunktpraxis Dr. Lorra / Dr. Bonnermann
Zentrum für klinische Studien Dresden, GWT-TUD GmbH
Gemeinschaftspraxis Partner der Gesundheit
IKFE Institute for Clinical Research and Development
Zentrum für Diabetes und Gefäßerkrankungen
Diabetes Zentrum Neuwied
ikfe Studiencenter Potsdam GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control arm

Saxagliptin & metformin

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

percentage of patients with stable HbA1c

Secondary Outcome Measures

impact of the switch on:

- Biomarkers of insulin resistance and ß-cell function

impact of the switch on:

- Biomarkers of cardiovaskular risk

impact of the switch on:

- Patient treatment satifaction

impact of the switch on:

- Treatment costs

impact of the switch on:

- Requirement of 3rd line OAD pioglitazone as rescue drug

impact of the switch on:

- oral Glucose Tolerance Test (oGTT)

impact of the switch on:

- Macrophagen activation (in a subpopulation at site 01 ikfe GmbH)

Full Information

NCT ID

NCT01206647

First Posted

September 15, 2010

Last Updated

September 21, 2010

Sponsor

ikfe-CRO GmbH

Collaborators

AstraZeneca, IKFE Institute for Clinical Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT01206647

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2010

Overall Recruitment Status

Unknown status

Study Start Date

February 2010 (undefined)

Primary Completion Date

February 2011 (Anticipated)

Study Completion Date

February 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

ikfe-CRO GmbH

Collaborators

AstraZeneca, IKFE Institute for Clinical Research and Development

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control arm

Arm Type

No Intervention

Arm Description

Arm Title

Saxagliptin & metformin

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Metformin and Saxagliptin

Intervention Description

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

Primary Outcome Measure Information:

Title

percentage of patients with stable HbA1c

Time Frame

26 ± 2 weeks (baseline to postbaseline values) at 4 week intervals

Secondary Outcome Measure Information:

Title

impact of the switch on:

Description

- Biomarkers of insulin resistance and ß-cell function

Time Frame