18-week add-on to Metformin Comparison of Saxagliptin and Sitagliptin in Adult Patients With Type 2 Diabetes (T2D)
This study has been completed.
Sponsor:
AstraZeneca
Collaborator:
Bristol-Myers Squibb
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00666458
First received: April 23, 2008
Last updated: March 5, 2010
Last verified: March 2010
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sitagliptin in addition with metformin.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes |
Drug: saxagliptin Drug: sitagliptin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 18-wk, International, Multi-centre, Randomized, Parallel-group, Double-Blind, Active-Controlled Phase IIIb Study to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin in Comparison With Sitagliptin in Combination With Metformin in Adult Patients With T2D Who Have Inadequate Glycaemic Control on Metformin Alone |
Resource links provided by NLM:
Drug Information available for:
Metformin
Metformin hydrochloride
Saxagliptin
Sitagliptin
Sitagliptin phosphate
U.S. FDA Resources
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Hemoglobin A1c (HbA1c) Change From Baseline to Week 18 [ Time Frame: Baseline, Week 18 ] [ Designated as safety issue: No ]Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.
Secondary Outcome Measures:
- Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18 [ Time Frame: Week 18 (Last Observation Carried Forward) ] [ Designated as safety issue: No ]Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18 (Full Analysis Set)
- Fasting Plasma Glucose Change From Baseline to Week 18 (mg/dL) [ Time Frame: Baseline, Week 18 (Last Observation Carried Forward) ] [ Designated as safety issue: No ]Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.
- Fasting Plasma Glucose Change From Baseline to Week 18 (mmol/L) [ Time Frame: Baseline, Week 18 (Last Observation Carried Forward) ] [ Designated as safety issue: No ]Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.
| Enrollment: | 822 |
| Study Start Date: | April 2008 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
saxagliptin add-on to metformin
|
Drug: saxagliptin
tablet, per oral, once daily
Other Name: Onglyza
|
|
Active Comparator: 2
sitagliptin add-on to metformin
|
Drug: sitagliptin
capsule, per oral, once daily
Other Name: Januvia
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosed with type 2 diabetes
- Treatment with metformin alone on stable doses of 1500 mg or higher per day for at least 8 weeks
Exclusion Criteria:
- Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketotic coma
- Insulin therapy within one year
- Previous treatment with DPP-4 inhibitor
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00666458
Hide Study Locations
Hide Study LocationsLocations
| Argentina | |
| Research Site | |
| Lanus, Buenos Aires, Argentina | |
| Research Site | |
| Mar Del Plata, Buenos Aires, Argentina | |
| Research Site | |
| Buenos Aires, Argentina | |
| Research Site | |
| Caba, Argentina | |
| Research Site | |
| Capital Federal, Argentina | |
| Research Site | |
| Ciudad de Buenos Aires, Argentina | |
| Research Site | |
| Cordoba, Argentina | |
| Research Site | |
| Rosario, Argentina | |
| Research Site | |
| Santa Fe, Argentina | |
| Belgium | |
| Research Site | |
| Aalst, Belgium | |
| Research Site | |
| Bonheiden, Belgium | |
| Research Site | |
| Brugge, Belgium | |
| Research Site | |
| Genk, Belgium | |
| Research Site | |
| Gozee, Belgium | |
| Research Site | |
| Hasselt, Belgium | |
| Research Site | |
| Liege, Belgium | |
| Research Site | |
| Saint-medard, Belgium | |
| Research Site | |
| Sint-gillis-waas, Belgium | |
| Research Site | |
| Tessenderlo, Belgium | |
| Research Site | |
| Thuillies, Belgium | |
| Denmark | |
| Research Site | |
| Aalborg, Denmark | |
| Research Site | |
| Arhus, Denmark | |
| Research Site | |
| Christiansfeld, Denmark | |
| Research Site | |
| Farso, Denmark | |
| Research Site | |
| Gentofte, Denmark | |
| Research Site | |
| Hobro, Denmark | |
| Research Site | |
| Kolding, Denmark | |
| Research Site | |
| Rodovre, Denmark | |
| Research Site | |
| Viborg, Denmark | |
| France | |
| Research Site | |
| Angers, France | |
| Research Site | |
| Chateau Gontier, France | |
| Research Site | |
| Corbeil Essonnes, France | |
| Research Site | |
| La Seyne Sur Mer, France | |
| Research Site | |
| Laval, France | |
| Research Site | |
| Le Lavandou, France | |
| Research Site | |
| Montrevault, France | |
| Research Site | |
| Saint Cyr, France | |
| Research Site | |
| Tierce, France | |
| Research Site | |
| Toulon, France | |
| Research Site | |
| Witry Les Reims, France | |
| Italy | |
| Research Site | |
| Bergamo, BG, Italy | |
| Research Site | |
| Foggia, FG, Italy | |
| Research Site | |
| Chiavari, GE, Italy | |
| Research Site | |
| Genova, GE, Italy | |
| Research Site | |
| Rozzano, MI, Italy | |
| Research Site | |
| Olbia, OT, Italy | |
| Research Site | |
| Padova, PD, Italy | |
| Research Site | |
| Pordenone, PN, Italy | |
| Research Site | |
| Mercato San Severino, SA, Italy | |
| Research Site | |
| Siena, SI, Italy | |
| Mexico | |
| Research Site | |
| Mexico, D.f., Mexico | |
| Research Site | |
| Guadalajara, Jalisco, Mexico | |
| Research Site | |
| Monterrey, Mexico | |
| Norway | |
| Research Site | |
| Alesund, Norway | |
| Research Site | |
| Elverum, Norway | |
| Research Site | |
| Halden, Norway | |
| Research Site | |
| Hamar, Norway | |
| Research Site | |
| Lierskogen, Norway | |
| Research Site | |
| Lillehammer, Norway | |
| Research Site | |
| Oslo, Norway | |
| Research Site | |
| Sandvika, Norway | |
| Research Site | |
| Strommen, Norway | |
| Research Site | |
| Svelvik, Norway | |
| South Africa | |
| Research Site | |
| Benoni, Gauteng, South Africa | |
| Research Site | |
| Johannesburg, Gauteng, South Africa | |
| Research Site | |
| Cape Town, Western Cape, South Africa | |
| Research Site | |
| Bloemfontein, South Africa | |
| Research Site | |
| Cape Town, South Africa | |
| Research Site | |
| Durban, South Africa | |
| Research Site | |
| Johannesburg, South Africa | |
| Research Site | |
| Kwa Zulu Natal, South Africa | |
| Research Site | |
| Pretoria, South Africa | |
| Sweden | |
| Research Site | |
| Boras, Sweden | |
| Research Site | |
| Degeberga, Sweden | |
| Research Site | |
| Finspang, Sweden | |
| Research Site | |
| Goteborg, Sweden | |
| Research Site | |
| Jonkoping, Sweden | |
| Research Site | |
| Odeshog, Sweden | |
| Research Site | |
| Orebro, Sweden | |
| Research Site | |
| Pitea, Sweden | |
| Research Site | |
| Rattvik, Sweden | |
| Research Site | |
| Skanor, Sweden | |
| Research Site | |
| Timra, Sweden | |
| Research Site | |
| Trollhattan, Sweden | |
| Research Site | |
| Uddevalla, Sweden | |
| Research Site | |
| Umea, Sweden | |
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
| Principal Investigator: | André Scheen, Professor | Clinical Pharmacology Unit, Liege, Belgium |
| Study Director: | Peter Öhman, MD, PhD | AstraZeneca, Wilmington, USA |
| Study Chair: | Deborah Price, MSc | AstraZeneca, Wilmington, USA |
More Information
No publications provided
| Responsible Party: | Peter Öhman, Medical Science Director, AstraZeneca Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00666458 History of Changes |
| Other Study ID Numbers: | D1680C00002, EudraCT number 2007-006095-11 |
| Study First Received: | April 23, 2008 |
| Results First Received: | March 5, 2010 |
| Last Updated: | March 5, 2010 |
| Health Authority: | Sweden: The National Board of Health and Welfare Norway: Norwegian Institute of Public Health Denmark: National Board of Health Italy: National Institute of Health France: Direction Générale de la Santé South Africa: Department of Health Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Brazil: Ministry of Health Mexico: Ministry of Health Belgium: Federal Agency for Medicines and Health Products, FAMHP |
Keywords provided by AstraZeneca:
|
Type 2 diabetes metformin |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Sitagliptin Saxagliptin 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 June 18, 2013