NCT00918879

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 Indian patients with inadequate glycaemic control with diet and exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
213

participants targeted

Target at P25-P50 for phase_3 type-2-diabetes

Timeline
Completed

Started May 2009

Shorter than P25 for phase_3 type-2-diabetes

Geographic Reach
1 country

9 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

Study Start

First participant enrolled

May 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 5, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 11, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 26, 2011

Completed
Last Updated

September 26, 2011

Status Verified

August 1, 2011

Enrollment Period

1.2 years

First QC Date

June 5, 2009

Results QC Date

June 28, 2011

Last Update Submit

August 18, 2011

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 glycosylated haemoglobin A1c (HbA1c) achieved with saxagliptin 5 mg versus placebo 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. HbA1c data were excluded on and after rescue medication.

    Baseline , Week 24

Secondary Outcomes (2)

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

    Baseline , Week 24

  • Proportion of Patients (Expressed in Percentage of Total Participants) Achieving a Therapeutic Glycemic Response Defined as HbA1c < 7.0% at Week 24

    Baseline , Week 24

Study Arms (2)

1

EXPERIMENTAL

Saxagliptin

Drug: Saxagliptin

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

SaxagliptinDRUG

Oral tablet, once daily for 24 weeks

Also known as: Onglyza
1
PlaceboDRUG

Oral tablet, once daily for 24 weeks

2

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with Type 2 diabetes
  • Patients should be drug naïve ie, not received medical treatment for diabetes
  • HbA1c ≥ 7.2% and ≤10.0% (at enrolment), HbA1c ≥ 7.0% and ≤10.0% (at randomization)

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 (9)

Research Site

Gujarat, Ahmedabad, India

Location

Research Site

Karnataka, Bangalore, India

Location

Research Site

Tamil Nadu, Chennai, India

Location

Research Site

Tamil Nadu, Coimbatore, India

Location

Research Site

Andhra Pradesh, Hyderabad, India

Location

Research Site

Madhya Pradesh, Indore, India

Location

Research Site

Haryāna, Karnal, India

Location

Research Site

Kerala, Kochi, India

Location

Research Site

Maharashtra, Pune, India

Location

Related Publications (1)

  • 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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

saxagliptin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com

Study Officials

  • Peter Ohman, MD, PhD

    AstraZeneca, Wilmington, USA

    STUDY DIRECTOR

  • Deborah Price, MSc

    AstraZeneca, Wilmington, USA

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

Study Record Dates

First Submitted

June 5, 2009

First Posted

June 11, 2009

Study Start

May 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

September 26, 2011

Results First Posted

September 26, 2011

Record last verified: 2011-08

Locations

IN(9)