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

NCT01206647 | Unknown Phase 4

• 1 other identifier: AZ-SAX-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 7

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• percentage of patients with stable HbA1c

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

Secondary Outcomes (7)

• impact of the switch on:

  26 ± 2 weeks (baseline to postbaseline values)

• impact of the switch on:

  26 ± 2 weeks (baseline to postbaseline values)

• impact of the switch on:

  26 ± 2 weeks (baseline to postbaseline values)

• impact of the switch on:

  26 ± 2 weeks (baseline to postbaseline values)

• impact of the switch on:

  26 ± 2 weeks (baseline to postbaseline values)

Study Arms (2)

Control arm

NO INTERVENTION

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 & metformin

EXPERIMENTAL

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

Interventions

Metformin and Saxagliptin DRUG

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

Saxagliptin & metformin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ikfe-CRO GmbH: lead
• AstraZeneca: collaborator
• IKFE Institute for Clinical Research and Development: collaborator

Study Sites (7)

Diabetologische Schwerpunktpraxis Dr. Lorra / Dr. Bonnermann

Bochum, 44869, Germany

Location

Zentrum für klinische Studien Dresden, GWT-TUD GmbH

Dresden, 01307, Germany

Location

Gemeinschaftspraxis Partner der Gesundheit

Essen, 45355, Germany

Location

IKFE Institute for Clinical Research and Development

Mainz, 55116, Germany

Location

Zentrum für Diabetes und Gefäßerkrankungen

Münster, 48145, Germany

Location

Diabetes Zentrum Neuwied

Neuwied, 56564, Germany

Location

ikfe Studiencenter Potsdam GmbH

Potsdam, 14469, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin; saxagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Andreas Pfützner, Prof.Dr.Dr.

  IKFE Institute for Clinical Research and Development

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 15, 2010
• First Posted: September 22, 2010
• Study Start: February 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: September 22, 2010

Record last verified: 2010-09

Locations

DE (7)