Type 2 DiabetesPhase 3NCT01257412
Evaluation of Efficacy and Safety of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Diet and Exercise Alone
A Phase 3 study testing Dapagliflozin in people with Type 2 Diabetes, run by AstraZeneca at 15 sites in India.
Trial summary
This study intends to compare the efficacy and safety of dapagliflozin versus placebo in treatment-naïve subjects with type 2 diabetes who have inadequate glycaemic control with diet and exercise alone. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 375 participants
- Where
- 15 sitesIndia
- Study dates
- Jan 2012to Jun 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent before participating in the study
- Diagnosed with type 2 diabetes (high blood sugar); HbA1c ≥ 7.2% and ≤10.0%
- Subjects should be drug naïve
- Women of childbearing potential who comply to use an adequate method of contraception to avoid pregnancy throughout the study \& who have a negative serum or urine pregnancy test
Who cannot join
- Subjects received Insulin therapy within one year of enrollment
- Subjects who have severe uncontrolled hypertension
- Subjects who have history of unstable or rapidly progressing renal disease
- Subjects who have severe liver disease
- Subjects who receiving treatment for Human immunodeficiency virus (HIV)
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
India15 sites
Research Site
Ahmedabad, Gujarat
Research Site
Bangalore, Karnataka
Research Site
Chennai, Tamil Nadu
Research Site
Coimbatore, Tamil Nadu
Research Site
Ghaziabad, Uttar Pradesh
Research Site
Hyderabad, Andhra Pradesh
Research Site
Indore, Madhya Pradesh
Research Site
Jaipur, Rajasthan
Research Site
Madurai, Tamil Nadu
Research Site
Mumbai, Maharashtra
Research Site
Mysore, Karnataka
Research Site
Nagpur, Maharashtra
Research Site
Pune, Maharashtra
Research Site
Trivandrum, Kerala
Research Site
Vijaywada, Andhra Pradesh
About this study
Official title: A 24-week National Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase III Trial in India to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Diet and Exercise Alone.
This study intends to compare the efficacy and safety of dapagliflozin versus placebo in treatment-naïve subjects with type 2 diabetes who have inadequate glycaemic control with diet and exercise alone.
- Conditions
- Type 2 Diabetes
- Being tested
- Dapagliflozin, placebo
- Keywords
- Phase III, Type 2 Diabetes Mellitus, inadequate glycaemic control
- 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.
DapagliflozinDrug
5mg Oral dose od
DapagliflozinDrug
10 mg Oral dose od
placeboDrug
5/10 mg Oral dose od
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Dapagliflozin |
| 2 | Experimental | Not described Receives: Drug: Dapagliflozin |
| 3 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in glycosylated haemoglobin A1c (HbA1c).
Measured: From baseline to week 24
Secondary outcomes (3)
mean change in fasting plasma glucose (FPG)
Measured: From baseline to week 24
mean change in 2- hour postprandial glucose by Mixed Meal Test
Measured: From baseline to week 24
mean change from baseline in fasting plasma glucose (FPG)
Measured: From baseline to week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2010 (estimated)
- Study startJan 2012
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Why it stopped: FSI delayed until 15 January 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Prof. A. Ramachandran, MD, PhD, Principal investigator, Dr. A. Ramachandran's Diabetes Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257412
- Sponsor's protocol ID
- D1693C00002
- Status last verified
- Feb 2012
- First submitted
- 8 Dec 2010
- Last updated
- 1 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-week National Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase III Trial in India to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Diet and Exercise Alone.
- ClinicalTrials.gov ID
- NCT01257412
- Acronym / sponsor ID
- D1693C00002
- Conditions
- Type 2 Diabetes
- Keywords
- Phase III, Type 2 Diabetes Mellitus, inadequate glycaemic control
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: FSI delayed until 15 January 2013
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Jan 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 9 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study intends to compare the efficacy and safety of dapagliflozin versus placebo in treatment-naïve subjects with type 2 diabetes who have inadequate glycaemic control with diet and exercise alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Dapagliflozin |
| 2 | Experimental | Drug: Dapagliflozin |
| 3 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of informed consent before participating in the study
- Diagnosed with type 2 diabetes (high blood sugar); HbA1c ≥ 7.2% and ≤10.0%
- Subjects should be drug naïve
- Women of childbearing potential who comply to use an adequate method of contraception to avoid pregnancy throughout the study \& who have a negative serum or urine pregnancy test
Key exclusion criteria (5 listed)
- Subjects received Insulin therapy within one year of enrollment
- Subjects who have severe uncontrolled hypertension
- Subjects who have history of unstable or rapidly progressing renal disease
- Subjects who have severe liver disease
- Subjects who receiving treatment for Human immunodeficiency virus (HIV)
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 |
|---|---|---|
| Dapagliflozin5mg Oral dose od | Drug | 1 |
| Dapagliflozin10 mg Oral dose od | Drug | 2 |
| placebo5/10 mg Oral dose od | Drug | 3 |
Primary outcome
change in glycosylated haemoglobin A1c (HbA1c).
Time frame: From baseline to week 24
3 secondary outcomes
mean change in fasting plasma glucose (FPG)
Time frame: From baseline to week 24
mean change in 2- hour postprandial glucose by Mixed Meal Test
Time frame: From baseline to week 24
mean change from baseline in fasting plasma glucose (FPG)
Time frame: From baseline to week 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2012.
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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.
Prof. A. Ramachandran, MD, PhD principal investigator
Dr. A. Ramachandran's Diabetes Hospital
15 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 Dapagliflozin in people with Type 2 Diabetes, run by AstraZeneca at 15 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 4 inclusion and 5 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: paused, as of the sponsor's last update on 1 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
Results are not available in the source record.
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?
change in glycosylated haemoglobin A1c (HbA1c). (time frame: From baseline to week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2012.