Efficacy and Safety of Dapagliflozin in Combination With Glimepiride (a Sulphonylurea) in Type 2 Diabetes Patients - Full Text View

Sponsor:	AstraZeneca
Collaborator:	Bristol-Myers Squibb
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00680745

Purpose

This study is being carried out to see if dapagliflozin in addition to glimepiride (sulphonylurea) is effective and safe in treating patients with type 2 diabetes when compared to glimepiride alone.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: dapagliflozin Drug: Glimepiride Drug: metformin hydrochloride Drug: pioglitazone hydrochloride Drug: Rosiglitazone	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A 24-Week,Int.,Rand.,Double-blind,Parallel-group,Multi-centre, Plac.-Controlled Phase III Study With a 24-Wk Ext.Per.to Eval.the Efficacy and Safety of Dapagliflozin in Comb.With Glimepiride (a Sulphonylurea) in Subjects With Type2 Diab.Who Have Inadeq. Glycaemic Control on Glimepiride Therapy Alone

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Glimepiride Pioglitazone Pioglitazone hydrochloride Rosiglitazone Rosiglitazone Maleate BMS 512148 Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To assess the efficacy of dapagliflozin compared to placebo as add-on therapy to glimepiride in improving glycaemic control in subjects with type 2 diabetes, as determined by the change in A1C levels from baseline to Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To show that dapagliflozin plus glimepiride results in greater reductions in body weight or less weight gain after 24 weeks of treatment when compared to placebo plus glimepiride. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
To show that dapagliflozin plus glimepiride results in greater reductions in the 2-h post-challenge plasma glucose level as a response to an oral glucose tolerance test (OGTT) from baseline to Week 24. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
To show that dapagliflozin plus glimepiride results in a larger proportion of subjects achieving a therapeutic glycaemic response, defined as A1C < 7% after 24 weeks of treatment, compared to placebo plus glimepiride. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment:	597
Study Start Date:	April 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental dapagliflozin 2.5mg + Glimepiride	Drug: dapagliflozin tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks Drug: Glimepiride tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks Drug: metformin hydrochloride rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice Drug: pioglitazone hydrochloride rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice Drug: Rosiglitazone rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
2: Experimental dapagliflozin 5mg + Glimepiride	Drug: dapagliflozin tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks Drug: Glimepiride tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks Drug: metformin hydrochloride rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice Drug: pioglitazone hydrochloride rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice Drug: Rosiglitazone rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
3: Experimental dapagliflozin 10mg + Glimepiride	Drug: dapagliflozin tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks Drug: Glimepiride tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks Drug: metformin hydrochloride rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice Drug: pioglitazone hydrochloride rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice Drug: Rosiglitazone rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
4: Placebo Comparator Placebo + Glimepiride	Drug: Glimepiride tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks Drug: metformin hydrochloride rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice Drug: pioglitazone hydrochloride rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice Drug: Rosiglitazone rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 Diabetes
Treatment with a stable sulphonylurea monotherapy dose that is at least half the maximal recommended dose for a minimum of 8 weeks prior to study
Inadequate glycaemic control, defined as A1C ≥ 7.0 % and ≤ 10%

Exclusion Criteria:

Type 1 Diabetes
Hepatic (liver) impairment
Renal (kidney) failure or dysfunction

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680745

Show 66 Study Locations

Sponsors and Collaborators

AstraZeneca

Bristol-Myers Squibb

Investigators

Principal Investigator:

Krzysztof Strojek, Prof. Dr.

Silesian Medical University3-Maja 13/15, 41-800 Zabrze; Poland

More Information

No publications provided

Responsible Party:	AstraZeneca Pharmaceuticals ( Shamik Parikh, MD Sr. Director, Medical Science )
Study ID Numbers:	D1690C00005
Study First Received:	May 16, 2008
Last Updated:	February 4, 2010
ClinicalTrials.gov Identifier:	NCT00680745 History of Changes
Health Authority:	Czech Republic: State Institute for Drug Control; Hungary: National Institute of Pharmacy; India: Central Drugs Standard Control Organization; India: Ministry of Health; Korea: Food and Drug Administration; Philippines: Bureau of Food and Drugs; Poland: Ministry of Health; Thailand: Food and Drug Administration; Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by AstraZeneca:

Dapagliflozin
efficacy
safety
sulphonylurea
Type 2 diabetes

Additional relevant MeSH terms:

Metabolic Diseases
Immunologic Factors
Pioglitazone
Metformin
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents
Immunosuppressive Agents

Pharmacologic Actions
Glimepiride
Hypoglycemic Agents
Therapeutic Uses
Diabetes Mellitus, Type 2
Anti-Arrhythmia Agents
Glucose Metabolism Disorders
Rosiglitazone

ClinicalTrials.gov processed this record on February 08, 2010