Type II Diabetes MellitusPhase 2ASI-DMIINCT00737152
Evaluate the Side Effects and Benefits of RAS 130 With or Without Diet and Exercise in Type II Diabetes Mellitus
A Phase 2 study testing RAS 130 with diet and exercise in people with Type II Diabetes Mellitus, run by American Scitech International at 5 sites in 2 countries.
Trial summary
Rationale: RAS 130 is an anti-diabetic agent used to lower the blood glucose level in Type II Diabetes mellitus (non-insulin-dependent diabetes) patients with proper diet and exercise. RAS 130 works by restoring proper response to insulin in the body. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Type II Diabetes Mellitus
- What is being tested?
- RAS 130 with diet and exercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jul 2011to Apr 2014
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with Type II Diabetes Mellitus (non-insulin-dependent), not taking any anti-diabetic agent.
- Fasting blood glucose level below 250mg/dL
- Age 30 to 60 years
- Both genders
- HbA1c of 6.0% to 13.0%, inclusive
- Body mass index (BMI) below 40 kg/m2
- Female subjects not pregnant, not lactating, post-menopausal, surgically sterile or using effective contraceptive measures are included.
- Provide signed Informed Consent
Who cannot join
- Subject unable to give Informed Consent
- Patients with Type I Diabetes Mellitus
- History of ketoacidosis
- Serum creatinine > 2.0 mg or above
- Liver Function Test; Elevated liver enzymes: ALT/AST (2.5 times the upper limit of the reference range), Bilirubin Testing - Accept three fold, A/G ratio - Accept two fold
- Hypercholesterolemia (more than 300mg)
Show all 24Show fewer
- Myocardial Infarction (MI) within 6 months
- Severe or unstable angina
- Elevated triglycerides >500 mg/dL
- Abnormal EKG reading
- Abnormal assessment in stress Echocardiography (ultrasound imaging)for Left Ventricular ejection fraction for congestive heart failure
- Anemia (Hb <11 g/dl for men or <10 g/dl for women)
- Blood Dyscrasia, Decrease in Hematocrit - Accept two fold, Low WBC count - Accept one fold, Decrease platelet count - Accept three fold
- Macular edema/ macular degeneration
- Patients who are taking insulin
- Subjects with systolic blood pressure >170 mmHg or diastolic blood pressure >90 mmHg
- Active participation in another trial
- Subject physically unable to perform exercise due to neurologic or orthopedic conditions.
- Patients taking antipsychotic medications.
- Subjects testing positive for the illicit drugs (cocaine, amphetamines, heroin)
- Subjects who smoke tobacco products
- Females who are lactating, pregnant, or planning to become pregnant
- Signs and symptoms of Congestive heart failure (such as shortness of breath or swelling in upper extremities)
- History of severe edema or a medically serious fluid retention
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States3 sites
MedCenter
East Brunswick, New Jersey, 08816
Ratna Grewal, MD, 908-941-5480, rgreywal@americanscitech.com
Sarath Babu, MD
Robertwood Johnson Hospital
New Brunswick, New Jersey, 08901
Ratna Grewal, MD, 908-941-5480, rgreywal@americanscitech.com
Xiangbing Wang, MD
Raritan Bay Medical Center
Perth Amboy, New Jersey, 08861
Ratna Grewal, MD, 908-941-5480, rgreywal@americanscitech.com
Prem Nandiwada, MD
India2 sites
Sri Ramachandra University
Porur, Chennai
Ratna Grewal, MD, 908-941-5480, rgreywal@americanscitech.com
S P Thyagarajan, Ph.D
Dr. JL Rohatagi Hospital
Sarvoday Nagar, Kanpur, Uttar Pradesh
Ratna Grewal, MD, 908-941-5480, rgreywal@americanscitech.com
S N Agarwal, MD
About this study
Official title: Phase II, Open-Label Study to Assess the Cardiovascular Side Effects and Efficacy for Reducing Blood Glucose Level in Type II Diabetes Mellitus Patients Being Treated With RAS 130 With or Without Diet and Exercise
Rationale: RAS 130 is an anti-diabetic agent used to lower the blood glucose level in Type II Diabetes mellitus (non-insulin-dependent diabetes) patients with proper diet and exercise. RAS 130 works by restoring proper response to insulin in the body. RAS 130 acts primarily by increasing insulin sensitivity which improves glycemic index. It is presumed that RAS 130 does not cause cardiovascular side effects if it is given to Type II diabetes mellitus patients leading a healthy life style. Specifically, controlling diet is done according to American Diabetic Association \& American Heart Association guidelines and also through doing aerobic exercises. Guideline for aerobic exercise is given in the design of the study.
Exercise is helpful in controlling body weight which can lower the risk for heart disease. Diabetes itself is one of the compounding factors for heart diseases. Exercise helps lowering the LDL cholesterol and raising the HDL cholesterol which is required to prevent heart diseases and achieve a better quality of life.
Purpose: The aim of this study is to prospectively assess and evaluate the cardiovascular side effects and reduction of blood glucose levels in the Type II Diabetes mellitus patients treated with RAS 130, who either met, or failed to meet criteria for diet and exercise.
Read the detailed description
Objectives:
Primary Objective:
To determine the relatedness of cardio toxicity as a side effect in subjects with DM II who are treated with RAS 130 who either met, or failed to meet the criteria for diet and exercise.
Hypothesis I: There will be no evidence of cardiovascular side effects in subjects who are determined to have maintained proper diet and exercise "healthy lifestyle" throughout the study.
Hypothesis II: There may be evidence of cardiovascular side effects in subjects who are determined to neglect proper diet and exercise "unhealthy lifestyle" throughout the study.
Secondary Objective:
To determine the effectiveness of RAS 130 on the reduction of blood glucose levels in subjects with DM II.
Hypothesis III: RAS 130 will be effective in reducing blood glucose levels as a single agent.
Hypothesis IV: RAS 130 will be effective in reducing blood glucose in combination with other anti- diabetic agents.
- Conditions
- Type II Diabetes Mellitus
- Being tested
- RAS 130 with diet and exercise
- Keywords
- RAS 130, Exercise, Diabetes Mellitus, Type II Diabetes, Diabetes, Aerobic
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAS 130 with diet and exerciseOther
Also called diet and exercise
Entire population, which will also include existing patients, will be treated with RAS 130 along with diet and exercise. By the end of 6 months: 3 months of study and 3 months of follow-up, the entire population will be divided into two groups which will be determined through endpoints. The first group will be subjects with diet and exercise and the second group will be subjects without diet and exercise. The endpoints for the division of the groups are given in the design of the study.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | All subjects will take RAS 130 administered orally in tablet form at a starting dose of 4 mg once a day or 2 mg tablets twice a day. Receives: Other: RAS 130 with diet and exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine cardiovascular side effects such as coronary artery disease (CAD) and congestive heart failure (CHF) in patients treated with RAS 130 along with diet and exercise.
Measured: 6 months
Secondary outcomes (1)
To determine the effect of RAS 130 on reduction of blood glucose level with or without diet and exercise
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2008 (estimated)
- Study startJul 2011
- Primary completionApr 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Scitech International
- Sponsor type
- University, hospital or other
- Collaborators
- Proactive Clinical Research
- Investigators
- Ratna Grewal, MD, Study chair, American Scitech International - eCROPrem Nandiwada, MD, Principal investigator, Raritan Bay Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00737152
- Sponsor's protocol ID
- ASI-DMII 0808
- Acronym
- ASI-DMII
- Status last verified
- Jul 2011
- First submitted
- 14 Aug 2008
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Open-Label Study to Assess the Cardiovascular Side Effects and Efficacy for Reducing Blood Glucose Level in Type II Diabetes Mellitus Patients Being Treated With RAS 130 With or Without Diet and Exercise
- ClinicalTrials.gov ID
- NCT00737152
- Acronym / sponsor ID
- ASI-DMII / ASI-DMII 0808
- Conditions
- Type II Diabetes Mellitus
- Keywords
- RAS 130, Exercise, Diabetes Mellitus, Type II Diabetes, Diabetes, Aerobic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- American Scitech InternationalUniversity, hospital or other
- Collaborators
- Proactive Clinical Research
- Study start
- Jul 2011
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 18 Aug 2008 (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.
Rationale: RAS 130 is an anti-diabetic agent used to lower the blood glucose level in Type II Diabetes mellitus (non-insulin-dependent diabetes) patients with proper diet and exercise. RAS 130 works by restoring proper response to insulin in the body. RAS 130 acts primarily by increasing insulin sensitivity which improves glycemic index. It is presumed that RAS 130 does not cause cardiovascular side effects if it is given to Type II diabetes mellitus patients leading a healthy life style. Specifically, controlling diet is done according to American Diabetic Association \& American Heart Association guidelines and also through doing aerobic exercises. Guideline for aerobic exercise is given in the design of the study.
Exercise is helpful in controlling body weight which can lower the risk for heart disease. Diabetes itself is one of the compounding factors for heart diseases. Exercise helps lowering the LDL cholesterol and raising the HDL cholesterol which is required to prevent heart diseases and achieve a better quality of life.
Purpose: The aim of this study is to prospectively assess and evaluate the cardiovascular side effects and reduction of blood glucose levels in the Type II Diabetes mellitus patients treated with RAS 130, who either met, or failed to meet criteria for diet and exercise.
Detailed description
Objectives:
Primary Objective:
To determine the relatedness of cardio toxicity as a side effect in subjects with DM II who are treated with RAS 130 who either met, or failed to meet the criteria for diet and exercise.
Hypothesis I: There will be no evidence of cardiovascular side effects in subjects who are determined to have maintained proper diet and exercise "healthy lifestyle" throughout the study.
Hypothesis II: There may be evidence of cardiovascular side effects in subjects who are determined to neglect proper diet and exercise "unhealthy lifestyle" throughout the study.
Secondary Objective:
To determine the effectiveness of RAS 130 on the reduction of blood glucose levels in subjects with DM II.
Hypothesis III: RAS 130 will be effective in reducing blood glucose levels as a single agent.
Hypothesis IV: RAS 130 will be effective in reducing blood glucose in combination with other anti- diabetic agents.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: RAS 130 with diet and exerciseAll subjects will take RAS 130 administered orally in tablet form at a starting dose of 4 mg once a day or 2 mg tablets twice a day. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients with Type II Diabetes Mellitus (non-insulin-dependent), not taking any anti-diabetic agent.
- Fasting blood glucose level below 250mg/dL
- Age 30 to 60 years
- Both genders
- HbA1c of 6.0% to 13.0%, inclusive
Key exclusion criteria (24 listed)
- Subject unable to give Informed Consent
- Patients with Type I Diabetes Mellitus
- Serum creatinine > 2.0 mg or above
- Liver Function Test; Elevated liver enzymes: ALT/AST (2.5 times the upper limit of the reference range), Bilirubin Testing - Accept three fold, A/G ratio - Accept two fold
- Hypercholesterolemia (more than 300mg)
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 |
|---|---|---|
| RAS 130 with diet and exerciseAlso: diet and exerciseEntire population, which will also include existing patients, will be treated with RAS 130 along with diet and exercise. By the end of 6 months: 3 months of study and 3 months of follow-up, the entire population will be divided into two groups which will be determined through endpoints. The first group will be subjects with diet and exercise and the second group will be subjects without diet and exercise. The endpoints for the division of the groups are given in the design of the study. | Other | 1 |
Primary outcome
To determine cardiovascular side effects such as coronary artery disease (CAD) and congestive heart failure (CHF) in patients treated with RAS 130 along with diet and exercise.
Time frame: 6 months
1 secondary outcome
To determine the effect of RAS 130 on reduction of blood glucose level with or without diet and exercise
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2011.
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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.
Ratna Grewal, MD study chair
American Scitech International - eCRO
Prem Nandiwada, MD principal investigator
Raritan Bay Medical Center
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RAS 130 with diet and exercise in people with Type II Diabetes Mellitus, run by American Scitech International at 5 sites in 2 countries.
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 8 inclusion and 24 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 20 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine cardiovascular side effects such as coronary artery disease (CAD) and congestive heart failure (CHF) in patients treated with RAS 130 along with diet and exercise. (time frame: 6 months). 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 20 Jul 2011.