Evaluate Saxagliptin in Adult Indian Patients With Type 2 Diabetes Inadequate Glycemic Control

A Phase 3 study testing Saxagliptin in people with Type 2 Diabetes, run by AstraZeneca at 9 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes
What is being tested?: Saxagliptin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 213 participants
Where: 9 sitesIndia
Study dates: May 2009to Jul 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

India9 sites

Research Site
Andhra Pradesh, Hyderabad
Research Site
Gujarat, Ahmedabad
Research Site
Haryāna, Karnal
Research Site
Karnataka, Bangalore
Research Site
Kerala, Kochi
Research Site
Madhya Pradesh, Indore
Research Site
Maharashtra, Pune
Research Site
Tamil Nadu, Chennai
Research Site
Tamil Nadu, Coimbatore

Other trials in India

About this study

Official title: A 24-Week National, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-controlled, Phase IIIb Study in India to Evaluate the Efficacy and Safety of Saxagliptin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Diet and Exercise

Conditions: Type 2 Diabetes
Being tested: Saxagliptin, Placebo
Keywords: DPP-4 inhibitors, HbA1c, Incretins
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SaxagliptinDrug
Also called Onglyza
Oral tablet, once daily for 24 weeks
PlaceboDrug
Oral tablet, once daily for 24 weeks

Study groups in NCT00918879
Study group	Role	What they receive
1	Experimental	Saxagliptin Receives: Drug: Saxagliptin
2	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline , Week 24

Secondary outcomes (2)

Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG)
Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo 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. FPG data were excluded on and after rescue medication.
Measured: 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
Proportion of participants (expressed in percentage of total participants)achieving HbA1c < 7.0% for saxagliptin versus placebo at Week 24 (LOCF, Full Analysis set). HbA1c data were excluded on and after rescue medication
Measured: Baseline , Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2009Jul 2010

First posted11 Jun 2009 (estimated)
Study startMay 2009
Primary completionJul 2010
Study completionJul 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 213 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00918879
Sponsor's protocol ID: D1680C00008
Status last verified: Aug 2011
First submitted: 5 Jun 2009
Last updated: 26 Sep 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 27402391

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 24-Week National, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-controlled, Phase IIIb Study in India to Evaluate the Efficacy and Safety of Saxagliptin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Diet and Exercise
ClinicalTrials.gov ID: NCT00918879
Acronym / sponsor ID: D1680C00008
Conditions: Type 2 Diabetes
Keywords: DPP-4 inhibitors, HbA1c, Incretins
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 213 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Bristol-Myers Squibb
Study start: May 2009
Primary completion: Jul 2010 (actual)
Study completion: Jul 2010 (actual)
First posted: 11 Jun 2009 (estimated)
Results: Posted 26 Sep 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: SaxagliptinSaxagliptin
2	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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)

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SaxagliptinAlso: OnglyzaOral tablet, once daily for 24 weeks	Drug	1
PlaceboOral tablet, once daily for 24 weeks	Drug	2

Primary outcome

Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)
Time frame: Baseline , Week 24
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.

2 secondary outcomes

Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG)
Time frame: 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
Time frame: Baseline , Week 24

Results and safety

Results posted to the registry on 26 Sep 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Saxagliptin 5 mg	107	101
Placebo	106	100

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

Time frame: Baseline , Week 24. Mean (Standard Error). Unit: percent

Measure	Saxagliptin 5 mg n = 104	Placebo n = 105
Baseline	8.33 (0.080)	8.33 (0.072)
Week 24	7.82 (0.116)	8.28 (0.114)
Adjusted Change from Baseline to Week 24	-0.51 (0.098)	-0.05 (0.098)

Saxagliptin 5 mg vs Placebo: Mean Difference (Net): -0.46 (95% CI -0.73 to -0.18), p = 0.0011, ANCOVA

Population analysed: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Wk 24(LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Saxagliptin 5 mg	0 of 107 (0%)	9 of 107 (8.4%)	Not reported
Placebo	0 of 106 (0%)	10 of 106 (9.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27402391Perl 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.

Related trials for Type 2 Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Peter Ohman, MD, PhD study director

AstraZeneca, Wilmington, USA

Deborah Price, MSc study chair

AstraZeneca, Wilmington, USA

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Saxagliptin in people with Type 2 Diabetes, run by AstraZeneca at 9 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c) (time frame: Baseline , Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00918879, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2011.