Type 2 Diabetes MellitusPhase 2NCT00836940
A Clinical Study of GRC 8200 in Type 2 Diabetes Mellitus
A Phase 2 study testing GRC 8200 in people with Type 2 Diabetes Mellitus, run by Glenmark Pharmaceuticals Europe Ltd. (R&D) at 1 site in India.
Trial summary
The study is aimed at evaluating efficacy and safety of GRC 8200 in type 2 diabetes mellitus patients. The study involves six weeks of wash out period and two weeks run in period for patients currently on mono-therapy and a two week run in period only for drug naïve patients. This is a placebo controlled study. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- GRC 8200
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2008to Oct 2009
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients ≥30 years of age
- At screening, females of non-childbearing potential or females of childbearing potential with adequate contraception
- Has an established clinical diagnosis of type 2 diabetes mellitus for at least 3 months prior to the screening period
- Is being treated for diabetes either with diet and exercise alone, or on monotherapy with any of the antidiabetic drugs
- Has an HbA1c value at screening between 6.5% and 10%
Who cannot join
- Has type 1 diabetes
- Is a female who is lactating or is pregnant
- Has a history of acute metabolic diabetic complications
- Has clinically significant disease other than type 2 diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 12-week Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate Safety, Tolerability, and Efficacy of GRC 8200, a New Oral DPP -IV Inhibitor, in Patients With Type 2 Diabetes Mellitus.
The study is aimed at evaluating efficacy and safety of GRC 8200 in type 2 diabetes mellitus patients.
The study involves six weeks of wash out period and two weeks run in period for patients currently on mono-therapy and a two week run in period only for drug naïve patients.
This is a placebo controlled study. One of the five treatment arms is placebo. The duration of treatment is 12 weeks.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- GRC 8200
- Keywords
- Type 2 diabetes mellitus, GRC 8200
- 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.
GRC 8200Drug
Capsules, 25 to 100mg, once/ twice a day, 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: GRC 8200 |
| 2 | Experimental | GRC 8200-25mg OD Receives: Drug: GRC 8200 |
| 3 | Experimental | GRC 8200-50mg OD Receives: Drug: GRC 8200 |
| 4 | Experimental | GRC 8200-50mg BD Receives: Drug: GRC 8200 |
| 5 | Experimental | GRC 8200-100mg OD Receives: Drug: GRC 8200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HbA1c compared with placebo at the end of 12 week treatment period
Measured: 12 weeks
Secondary outcomes (8)
Change in HbA1c from baseline at the end of 4 and 8 weeks of treatment
Measured: 4 and 8 weeks
Fasting plasma glucose and fasting serum insulin
Measured: 12 weeks
Plasma glucose 2 hours post glucose challenge (OGTT)
Measured: 12 weeks
HOMA-IR
Measured: 12 weeks
HOMA-B
Measured: 12 weeks
Change in serum lipids
Measured: 12 weeks
Body weight
Measured: 12 weeks
Waist circumference
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startJun 2008
- Primary completionMay 2009
- Study completionOct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glenmark Pharmaceuticals Europe Ltd. (R&D)
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836940
- Sponsor's protocol ID
- GRC 8200-301
- Status last verified
- Sep 2009
- First submitted
- 3 Feb 2009
- Last updated
- 24 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate Safety, Tolerability, and Efficacy of GRC 8200, a New Oral DPP -IV Inhibitor, in Patients With Type 2 Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT00836940
- Acronym / sponsor ID
- GRC 8200-301
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 diabetes mellitus, GRC 8200
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Glenmark Pharmaceuticals Europe Ltd. (R&D)Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Oct 2009 (estimated)
- First posted
- 4 Feb 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 study is aimed at evaluating efficacy and safety of GRC 8200 in type 2 diabetes mellitus patients.
The study involves six weeks of wash out period and two weeks run in period for patients currently on mono-therapy and a two week run in period only for drug naïve patients.
This is a placebo controlled study. One of the five treatment arms is placebo. The duration of treatment is 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: GRC 8200 |
| 2 | Experimental | Drug: GRC 8200GRC 8200-25mg OD |
| 3 | Experimental | Drug: GRC 8200GRC 8200-50mg OD |
| 4 | Experimental | Drug: GRC 8200GRC 8200-50mg BD |
| 5 | Experimental | Drug: GRC 8200GRC 8200-100mg OD |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients ≥30 years of age
- At screening, females of non-childbearing potential or females of childbearing potential with adequate contraception
- Has an established clinical diagnosis of type 2 diabetes mellitus for at least 3 months prior to the screening period
- Is being treated for diabetes either with diet and exercise alone, or on monotherapy with any of the antidiabetic drugs
- Has an HbA1c value at screening between 6.5% and 10%
Key exclusion criteria (4 listed)
- Has type 1 diabetes
- Is a female who is lactating or is pregnant
- Has a history of acute metabolic diabetic complications
- Has clinically significant disease other than type 2 diabetes mellitus
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 |
|---|---|---|
| GRC 8200Capsules, 25 to 100mg, once/ twice a day, 12 weeks | Drug | 1, 2, 3, 4, 5 |
Primary outcome
Change from baseline in HbA1c compared with placebo at the end of 12 week treatment period
Time frame: 12 weeks
8 secondary outcomes
Change in HbA1c from baseline at the end of 4 and 8 weeks of treatment
Time frame: 4 and 8 weeks
Fasting plasma glucose and fasting serum insulin
Time frame: 12 weeks
Plasma glucose 2 hours post glucose challenge (OGTT)
Time frame: 12 weeks
HOMA-IR
Time frame: 12 weeks
HOMA-B
Time frame: 12 weeks
Change in serum lipids
Time frame: 12 weeks
Body weight
Time frame: 12 weeks
Waist circumference
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2009.
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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.
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 2 study testing GRC 8200 in people with Type 2 Diabetes Mellitus, run by Glenmark Pharmaceuticals Europe Ltd. (R&D) 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 24 Sep 2009. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 from baseline in HbA1c compared with placebo at the end of 12 week treatment period (time frame: 12 weeks). 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 24 Sep 2009.