search
Back to results

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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Saxagliptin
Placebo
Metformin
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring DPP-4 inhibitors, HbA1c, Incretins

Eligibility Criteria

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

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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Metformin + Saxagliptin

Metformin + Placebo

Outcomes

Primary Outcome Measures

Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)
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

Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mmol/L
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.
Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mg/dL
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.
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
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.
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
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.
Proportion of Patients Achieving a Therapeutic Glycemic Response
Proportion of participants achieving a therapeutic glycemic response, defined as having HbA1c < 7.0% for saxagliptin + metformin versus placebo + metformin at week 24

Full Information

First Posted
April 17, 2008
Last Updated
February 6, 2012
Sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb
search

1. Study Identification

Unique Protocol Identification Number
NCT00661362
Brief Title
Evaluate Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes
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 Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
DPP-4 inhibitors, HbA1c, Incretins

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
570 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Metformin + Saxagliptin
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Metformin + Placebo
Intervention Type
Drug
Intervention Name(s)
Saxagliptin
Other Intervention Name(s)
Onglyza
Intervention Description
Oral tablet, once daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral tablet, once daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Glucophage
Intervention Description
oral tablet, once daily for 24 weeks
Primary Outcome Measure Information:
Title
Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)
Description
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.
Time Frame
Baseline , Week 24
Secondary Outcome Measure Information:
Title
Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mmol/L
Description
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.
Time Frame
Baseline , Week 24
Title
Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mg/dL
Description
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.
Time Frame
Baseline , Week 24
Title
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
Description
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.
Time Frame
Baseline , Week 24
Title
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
Description
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.
Time Frame
Baseline , Week 24
Title
Proportion of Patients Achieving a Therapeutic Glycemic Response
Description
Proportion of participants achieving a therapeutic glycemic response, defined as having HbA1c < 7.0% for saxagliptin + metformin versus placebo + metformin at week 24
Time Frame
Baseline , Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Ohman, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Deborah Price, MSc
Organizational Affiliation
AstraZeneca
Official's Role
Study Chair
Facility Information:
Facility Name
Research Site
City
Hefei
State/Province
Anhui
Country
China
Facility Name
Research Site
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Research Site
City
Shi Jiazhuang
State/Province
Hebei
Country
China
Facility Name
Research Site
City
Ha'er Bing
State/Province
Hei Longjiang
Country
China
Facility Name
Research Site
City
Wuhan
State/Province
Hu Bei
Country
China
Facility Name
Research Site
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Research Site
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Research Site
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Research Site
City
Dalian
State/Province
Liaoning
Country
China
Facility Name
Research Site
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Research Site
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Research Site
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Research Site
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Research Site
City
Beijing
Country
China
Facility Name
Research Site
City
Chongqing
Country
China
Facility Name
Research Site
City
Tianjin
Country
China
Facility Name
Research Site
City
Hyderabad
State/Province
Andhra Pradesh
Country
India
Facility Name
Research Site
City
Bangalore
State/Province
Karnataka
Country
India
Facility Name
Research Site
City
Mangalore
State/Province
Karnataka
Country
India
Facility Name
Research Site
City
Nagpur
State/Province
Maharashtra
Country
India
Facility Name
Research Site
City
Bangalore
Country
India
Facility Name
Research Site
City
Seongnam
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Research Site
City
Bucheon
Country
Korea, Republic of
Facility Name
Research Site
City
Daegu
Country
Korea, Republic of
Facility Name
Research Site
City
Goyang
Country
Korea, Republic of
Facility Name
Research Site
City
Gwangju
Country
Korea, Republic of
Facility Name
Research Site
City
Incheon
Country
Korea, Republic of
Facility Name
Research Site
City
Pusan
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
Country
Korea, Republic of
Facility Name
Research Site
City
Uijeongbu-si
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
27402391
Citation
Perl S, Cook W, Wei C, Iqbal N, Hirshberg B. Saxagliptin Efficacy and Safety in Patients With Type 2 Diabetes and Moderate Renal Impairment. Diabetes Ther. 2016 Sep;7(3):527-35. doi: 10.1007/s13300-016-0184-9. Epub 2016 Jul 11.
Results Reference
derived
PubMed Identifier
21871686
Citation
Yang W, Pan CY, Tou C, Zhao J, Gause-Nilsson I. Efficacy and safety of saxagliptin added to metformin in Asian people with type 2 diabetes mellitus: a randomized controlled trial. Diabetes Res Clin Pract. 2011 Nov;94(2):217-24. doi: 10.1016/j.diabres.2011.07.035. Epub 2011 Aug 26.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs