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Evaluate Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00661362
Recruitment Status : Completed
First Posted : April 18, 2008
Results First Posted : March 8, 2012
Last Update Posted : March 8, 2012
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult patients who have inadequate glycaemic control when treated with metformin in addition to diet and exercise.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Saxagliptin Drug: Placebo Drug: Metformin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 570 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 24-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-Controlled, Phase III Study to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy
Study Start Date : June 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Metformin + Saxagliptin
Drug: Saxagliptin
Oral tablet, once daily for 24 weeks
Other Name: Onglyza

Drug: Metformin
oral tablet, once daily for 24 weeks
Other Name: Glucophage

Placebo Comparator: 2
Metformin + Placebo
Drug: Placebo
oral tablet, once daily for 24 weeks

Drug: Metformin
oral tablet, once daily for 24 weeks
Other Name: Glucophage




Primary Outcome Measures :
  1. Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c) [ Time Frame: Baseline , Week 24 ]
    Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. *Adjusted for baseline HbA1c.


Secondary Outcome Measures :
  1. Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mmol/L [ Time Frame: Baseline , Week 24 ]
    Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (Last Observation Carried Out (LOCF), Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. *Adjusted for baseline FPG.

  2. Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mg/dL [ Time Frame: Baseline , Week 24 ]
    Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. *Adjusted for baseline FPG.

  3. Change From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup [ Time Frame: Baseline , Week 24 ]
    Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. The change from baseline for each subject is calculated as the week 24 value minus the baseline value. *Adjusted for baseline PPG AUC.

  4. Change From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup [ Time Frame: Baseline , Week 24 ]
    Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg + metformin versus placebo+metformin at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. The change from baseline for each subject is calculated as the week 24 value minus the baseline value. *Adjusted for baseline PPG AUC.

  5. Proportion of Patients Achieving a Therapeutic Glycemic Response [ Time Frame: Baseline , Week 24 ]
    Proportion of participants achieving a therapeutic glycemic response, defined as having HbA1c < 7.0% for saxagliptin + metformin versus placebo + metformin at week 24



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with Type 2 diabetes
  • Treatment with metformin at a stable dose >1500 mg/day
  • HbA1c ≥ 7.0% and ≤10.0%

Exclusion Criteria:

  • Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)
  • Type 1 diabetes, history of ketoacidosis, or hyperosmolar non-ketonic koma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00661362


Locations
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China, Anhui
Research Site
Hefei, Anhui, China
China, Guangdong
Research Site
Guangzhou, Guangdong, China
China, Hebei
Research Site
Shi Jiazhuang, Hebei, China
China, Hei Longjiang
Research Site
Ha'er Bing, Hei Longjiang, China
China, Hu Bei
Research Site
Wuhan, Hu Bei, China
China, Hunan
Research Site
Changsha, Hunan, China
China, Jiangsu
Research Site
Nanjing, Jiangsu, China
China, Jilin
Research Site
Changchun, Jilin, China
China, Liaoning
Research Site
Dalian, Liaoning, China
Research Site
Shenyang, Liaoning, China
China, Shanghai
Research Site
Shanghai, Shanghai, China
China, Sichuan
Research Site
Chengdu, Sichuan, China
China, Zhejiang
Research Site
Hangzhou, Zhejiang, China
China
Research Site
Beijing, China
Research Site
Chongqing, China
Research Site
Tianjin, China
India
Research Site
Hyderabad, Andhra Pradesh, India
Research Site
Bangalore, Karnataka, India
Research Site
Mangalore, Karnataka, India
Research Site
Nagpur, Maharashtra, India
Research Site
Bangalore, India
Korea, Republic of
Research Site
Seongnam, Gyeonggi-do, Korea, Republic of
Research Site
Bucheon, Korea, Republic of
Research Site
Daegu, Korea, Republic of
Research Site
Goyang, Korea, Republic of
Research Site
Gwangju, Korea, Republic of
Research Site
Incheon, Korea, Republic of
Research Site
Pusan, Korea, Republic of
Research Site
Seoul, Korea, Republic of
Research Site
Uijeongbu-si, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
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Study Director: Peter Ohman, MD AstraZeneca
Study Chair: Deborah Price, MSc AstraZeneca
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00661362    
Other Study ID Numbers: D1680C00006
First Posted: April 18, 2008    Key Record Dates
Results First Posted: March 8, 2012
Last Update Posted: March 8, 2012
Last Verified: February 2012
Keywords provided by AstraZeneca:
DPP-4 inhibitors
HbA1c
Incretins
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Saxagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action