NCT00661362

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
570

participants targeted

Target at P50-P75 for phase_3 type-2-diabetes

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_3 type-2-diabetes

Geographic Reach
3 countries

30 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 18, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

March 8, 2012

Completed
Last Updated

March 8, 2012

Status Verified

February 1, 2012

Enrollment Period

1.3 years

First QC Date

April 17, 2008

Results QC Date

September 20, 2010

Last Update Submit

February 6, 2012

Conditions

Type 2 Diabetes

Keywords

DPP-4 inhibitorsHbA1cIncretins

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline , Week 24

Secondary Outcomes (5)

  • Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mmol/L

    Baseline , Week 24

  • Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mg/dL

    Baseline , Week 24

  • 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

    Baseline , Week 24

  • 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

    Baseline , Week 24

  • Proportion of Patients Achieving a Therapeutic Glycemic Response

    Baseline , Week 24

Study Arms (2)

1

EXPERIMENTAL

Metformin + Saxagliptin

Drug: SaxagliptinDrug: Metformin

2

PLACEBO COMPARATOR

Metformin + Placebo

Drug: PlaceboDrug: Metformin

Interventions

SaxagliptinDRUG

Oral tablet, once daily for 24 weeks

Also known as: Onglyza
1
PlaceboDRUG

oral tablet, once daily for 24 weeks

2
MetforminDRUG

oral tablet, once daily for 24 weeks

Also known as: Glucophage
12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Research Site

Hefei, Anhui, China

Location

Research Site

Beijing, China, China

Location

Research Site

Chongqing, China, China

Location

Research Site

Guangzhou, Guangdong, China

Location

Research Site

Shijiazhuang, Hebei, China

Location

Research Site

Ha'er Bing, Hei Longjiang, China

Location

Research Site

Wuhan, Hubei, China

Location

Research Site

Changsha, Hunan, China

Location

Research Site

Nanjing, Jiangsu, China

Location

Research Site

Changchun, Jilin, China

Location

Research Site

Dalian, Liaoning, China

Location

Research Site

Shenyang, Liaoning, China

Location

Research Site

Shanghai, Shanghai Municipality, China

Location

Research Site

Chengdu, Sichuan, China

Location

Research Site

Hangzhou, Zhejiang, China

Location

Research Site

Tianjin, China

Location

Research Site

Hyderabad, Andhra Pradesh, India

Location

Research Site

Bangalore, Karnataka, India

Location

Research Site

Mangalore, Karnataka, India

Location

Research Site

Nagpur, Maharashtra, India

Location

Research Site

Bangalore, India

Location

Research Site

Seongnam-si, Gyeonggi-do, South Korea

Location

Research Site

Bucheon-si, South Korea

Location

Research Site

Daegu, South Korea

Location

Research Site

Goyang, South Korea

Location

Research Site

Gwangju, South Korea

Location

Research Site

Incheon, South Korea

Location

Research Site

Pusan, South Korea

Location

Research Site

Seoul, South Korea

Location

Research Site

Uijeongbu-si, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 27402391DERIVED

  • 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.

    PMID: 21871686DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

saxagliptinMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com

Study Officials

  • Peter Ohman, MD

    AstraZeneca

    STUDY DIRECTOR

  • Deborah Price, MSc

    AstraZeneca

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2008

First Posted

April 18, 2008

Study Start

June 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

March 8, 2012

Results First Posted

March 8, 2012

Record last verified: 2012-02

Locations

CN(16)IN(5)KR(9)