Type 2 DiabetesPhase 3SITAGLIPTINNCT01038648
Sitagliptin in Prevention of Type 2 Diabetes Mellitus
A Phase 3 study testing Sitagliptin and life style modification at base line in people with Type 2 Diabetes, run by India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals at 1 site in India.
Trial summary
The hypothesis is, in subjects with persistent impaired glucose tolerance(IGT) , sitagliptin will decrease the conversion rate to diabetes as compared to a placebo in three years. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Sitagliptin and life style modification at base line
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2011to Dec 2014
- 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 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects with IGT in the age group of 30-55 years (n=900) will be identified by screening with a standard OGTT.
Who cannot join
- Known diabetes
- Pregnant women
- Alcohol abuse
- Transferable jobs.
- Subjects with major illness like cancer, hepatic or cardiac diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does the DPP4 Inhibitor Sitagliptin Have a Role in Preventing Type 2 Diabetes- A Randomised Controlled Study.
The hypothesis is, in subjects with persistent impaired glucose tolerance(IGT) , sitagliptin will decrease the conversion rate to diabetes as compared to a placebo in three years.
Read the detailed description
The DPP-4 inhibitor Sitagliptin may be a suitable preventive agent in subjects with IGT or IFG on account of observed functional improvements in islet cell function and potential protective effect on beta cell mass.
Objectives of the study
- Primary objectives :
- To test whether the DPP4 inhibitor Sitagliptin is effective in preventing conversion of IGT to diabetes when compared with a placebo.
- Secondary objectives:
- To assess rates of reversal from IGT to Normal Glucose Tolerance (NGT) in IGT patients administered Sitagliptin
- To assess the effect of Sitagliptin on measure of beta cell function and insulin resistance in patients with IGT.
Study design
Double blind placebo controlled, parallel group study - three years follow up .
Subjects with IGT in the age group of 30-55 years (n=900) will be identified by screening with a standard OGTT. Selected subjects will be randomized to the control arm using placebo and the two study arms using Sitagliptin. At baseline all group will receive a standard advice on lifestyle modification. The dose of sitagliptin will be 100 mg/d. The subjects will be reviewed at 6 monthly intervals and repeat OGTT will be done annually.
Proforma containing details of anthropometry, occupation, physical activity, diet habits, details of medications, regularity of treatment and biochemical investigations will be filled up at each interview.
Investigations:
Initial Screening
- Demographic data
- Height, weight, waist and hip measurements.
- Details of family history of diabetes, hypertension and cardiovascular diseases.
- History of any other major illness.
- History of blood pressure and measurements.
- Details of education and occupation.
- Diet habits will be analyzed by dietician.
- Details of physical activity will be assessed by a questionnaire.
Laboratory investigations:
- Initial OGTT
- Plasma glucose and HbA1c.
- Lipid profile
- Liver function tests
- Serum amylase and serum lipase
- Plasma insulin
- 12 lead ECG.
Review analysis:
- Review will be done with all clinical and biochemical assessment annually.
- Evaluation of adherence to prescription will be done at 6 monthly intervals.
- Conditions
- Type 2 Diabetes
- Being tested
- Sitagliptin, life style modification at base line
- Keywords
- Sitagliptin, Type 2 diabetes, Prevention of type 2 diabetes
- 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.
SitagliptinDrug
100mg/day
life style modification at base lineOther
Advice on physical activity, diet and drug adherence.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Advice life style at baseline only Receives: Other: life style modification at base line |
| sitagliptin arm : 2 | Active comparator | 100mg/day sitagliptin
advice on life style modification at baseline only Receives: Drug: Sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Rate of conversion of IGT to diabetes. 2. Relative reduction of incidence of diabetes by Sitagliptin among people with IGT compared to Placebo. 3. Increase in reversal of IGT to NGT
Measured: At intervals -6 months
Secondary outcomes (1)
1. Beneficial effects in beta cell function. 2. Changes in insulin resistance 3. Improvement in cardiovascular risk factors by Sitagliptin.
Measured: Annual
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startDec 2011
- Primary completionFeb 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038648
- Sponsor's protocol ID
- SITAGLIPTIN-003 IDRF
- Acronym
- SITAGLIPTIN
- Status last verified
- Dec 2015
- First submitted
- 22 Dec 2009
- Last updated
- 30 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
1.Ramachandran A, Ronald Ma, Snehalatha C. Diabetes in Asia. 2009 Lancet Oct;DOI:10.1016/S0140-6736(09)60937-5. 2.Snehalatha C, Mary S, Selvam S, Sathish Kumar CK, Shetty SB, Nanditha A, Ramachandran A. Changes in insulin secretion and insulin sensitivity in relation to the glycemic outcomes in subjects with impaired glucose tolerance in the Indian Diabetes Prevention Programme-1 (IDPP-1).Diabetes Care. 2009 Oct;32(10):1796-801. 3.Ramachandran A, Snehalatha C, Mary S, Selvam S, Sathish Kumar CK, Catherin Seeli A, Samith Shetty A. Pioglitazone does not enhance effectiveness of life style modification in prevening conversion of impaired glucose tolerance to diabetes in Asian Indians-Results of Indian Diabetes Prevention Programme- (IDPP-2).Diabetologia 2009; 52: 1019 - 1026. 4.Ramachandran A, Snehalatha C. Cardiovascular risk factors in normoglycaemic Asian Indian population-Impact of urbanization. Diabetologia 2009 52; 596-599.
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the DPP4 Inhibitor Sitagliptin Have a Role in Preventing Type 2 Diabetes- A Randomised Controlled Study.
- ClinicalTrials.gov ID
- NCT01038648
- Acronym / sponsor ID
- SITAGLIPTIN / SITAGLIPTIN-003 IDRF
- Conditions
- Type 2 Diabetes
- Keywords
- Sitagliptin, Type 2 diabetes, Prevention of type 2 diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes HospitalsUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 24 Dec 2009 (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.
The hypothesis is, in subjects with persistent impaired glucose tolerance(IGT) , sitagliptin will decrease the conversion rate to diabetes as compared to a placebo in three years.
Detailed description
The DPP-4 inhibitor Sitagliptin may be a suitable preventive agent in subjects with IGT or IFG on account of observed functional improvements in islet cell function and potential protective effect on beta cell mass.
Objectives of the study
- Primary objectives :
- To test whether the DPP4 inhibitor Sitagliptin is effective in preventing conversion of IGT to diabetes when compared with a placebo.
- Secondary objectives:
- To assess rates of reversal from IGT to Normal Glucose Tolerance (NGT) in IGT patients administered Sitagliptin
- To assess the effect of Sitagliptin on measure of beta cell function and insulin resistance in patients with IGT.
Study design
Double blind placebo controlled, parallel group study - three years follow up .
Subjects with IGT in the age group of 30-55 years (n=900) will be identified by screening with a standard OGTT. Selected subjects will be randomized to the control arm using placebo and the two study arms using Sitagliptin. At baseline all group will receive a standard advice on lifestyle modification. The dose of sitagliptin will be 100 mg/d. The subjects will be reviewed at 6 monthly intervals and repeat OGTT will be done annually.
Proforma containing details of anthropometry, occupation, physical activity, diet habits, details of medications, regularity of treatment and biochemical investigations will be filled up at each interview.
Investigations:
Initial Screening
- Demographic data
- Height, weight, waist and hip measurements.
- Details of family history of diabetes, hypertension and cardiovascular diseases.
- History of any other major illness.
- History of blood pressure and measurements.
- Details of education and occupation.
- Diet habits will be analyzed by dietician.
- Details of physical activity will be assessed by a questionnaire.
Laboratory investigations:
- Initial OGTT
- Plasma glucose and HbA1c.
- Lipid profile
- Liver function tests
- Serum amylase and serum lipase
- Plasma insulin
- 12 lead ECG.
Review analysis:
- Review will be done with all clinical and biochemical assessment annually.
- Evaluation of adherence to prescription will be done at 6 monthly intervals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Other: life style modification at base lineAdvice life style at baseline only |
| sitagliptin arm : 2 | Active comparator | Drug: Sitagliptin100mg/day sitagliptin advice on life style modification at baseline only |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects with IGT in the age group of 30-55 years (n=900) will be identified by screening with a standard OGTT.
Key exclusion criteria (5 listed)
- Known diabetes
- Pregnant women
- Alcohol abuse
- Transferable jobs.
- Subjects with major illness like cancer, hepatic or cardiac diseases.
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 |
|---|---|---|
| Sitagliptin100mg/day | Drug | sitagliptin arm : 2 |
| life style modification at base lineAdvice on physical activity, diet and drug adherence. | Other | 1 |
Primary outcome
1. Rate of conversion of IGT to diabetes. 2. Relative reduction of incidence of diabetes by Sitagliptin among people with IGT compared to Placebo. 3. Increase in reversal of IGT to NGT
Time frame: At intervals -6 months
1 secondary outcome
1. Beneficial effects in beta cell function. 2. Changes in insulin resistance 3. Improvement in cardiovascular risk factors by Sitagliptin.
Time frame: Annual
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2015.
- Background1.Ramachandran A, Ronald Ma, Snehalatha C. Diabetes in Asia. 2009 Lancet Oct;DOI:10.1016/S0140-6736(09)60937-5. 2.Snehalatha C, Mary S, Selvam S, Sathish Kumar CK, Shetty SB, Nanditha A, Ramachandran A. Changes in insulin secretion and insulin sensitivity in relation to the glycemic outcomes in subjects with impaired glucose tolerance in the Indian Diabetes Prevention Programme-1 (IDPP-1).Diabetes Care. 2009 Oct;32(10):1796-801. 3.Ramachandran A, Snehalatha C, Mary S, Selvam S, Sathish Kumar CK, Catherin Seeli A, Samith Shetty A. Pioglitazone does not enhance effectiveness of life style modification in prevening conversion of impaired glucose tolerance to diabetes in Asian Indians-Results of Indian Diabetes Prevention Programme- (IDPP-2).Diabetologia 2009; 52: 1019 - 1026. 4.Ramachandran A, Snehalatha C. Cardiovascular risk factors in normoglycaemic Asian Indian population-Impact of urbanization. Diabetologia 2009 52; 596-599.
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
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sitagliptin and life style modification at base line in people with Type 2 Diabetes, run by India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals at 1 site 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 1 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: withdrawn, as of the sponsor's last update on 30 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
1. Rate of conversion of IGT to diabetes. 2. Relative reduction of incidence of diabetes by Sitagliptin among people with IGT compared to Placebo. 3. Increase in reversal of IGT to NGT (time frame: At intervals -6 months). 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 NCT01038648, 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 30 Dec 2015.