RISE Adult Medication Study
Overview[ - collapse ][ - ]
Purpose | The RISE Adult Medication Study is a 4-arm, 3-center, clinical trial of adults with prediabetes and early type 2 diabetes to address the hypothesis that aggressive glucose lowering will lead to recovery of beta-cell function that will be sustained after withdrawal of treatment. Adult participants (ages 20-65) will be randomized to one of the following treatment regimens: (1) blinded placebo, (2) blinded metformin alone, (3) early intensive insulin treatment with basal insulin glargine followed by open-label metformin, (4) the glucagon-like peptide-1 receptor agonist (GLP-1RA) liraglutide plus open-label metformin. The primary clinical question RISE will address is: Are improvements in ß-cell function following 12 months of active treatment maintained for 3 months following the withdrawal of therapy? Secondary outcomes will assess durability of glucose tolerance following withdrawal of therapy, and whether biomarkers obtained in the fasting state predict parameters of ß-cell function, insulin sensitivity and glucose tolerance and the response to an intervention. |
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Condition | Prediabetes Type 2 Diabetes |
Intervention | Drug: Metformin Drug: Liraglutide Drug: Glargine |
Phase | Phase 3 |
Sponsor | RISE Study Group |
Responsible Party | RISE Study Group |
ClinicalTrials.gov Identifier | NCT01779362 |
First Received | January 28, 2013 |
Last Updated | December 19, 2013 |
Last verified | May 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | January 28, 2013 |
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Last Updated Date | December 19, 2013 |
Start Date | April 2013 |
Estimated Primary Completion Date | August 2017 |
Current Primary Outcome Measures | ß-cell function measured by hyperglycemic clamp techniques [Time Frame: 3-months after a medication washout] [Designated as safety issue: No]Participants will have 12-months of active therapy and 3-months of washout after which the primary outcome will be assessed. |
Current Secondary Outcome Measures | Hyperglycemic clamp and oral glucose tolerance test (OGTT) measures of ß-cell function and glucose tolerance [Time Frame: 3-months after a medication washout] [Designated as safety issue: No]Measures derived from the hyperglycemic clamp that are not specified as primary outcomes and measures derived from the OGTT. |
Descriptive Information[ + expand ][ + ]
Brief Title | RISE Adult Medication Study |
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Official Title | Restoring Insulin Secretion Adult Medication Study |
Brief Summary | The RISE Adult Medication Study is a 4-arm, 3-center, clinical trial of adults with prediabetes and early type 2 diabetes to address the hypothesis that aggressive glucose lowering will lead to recovery of beta-cell function that will be sustained after withdrawal of treatment. Adult participants (ages 20-65) will be randomized to one of the following treatment regimens: (1) blinded placebo, (2) blinded metformin alone, (3) early intensive insulin treatment with basal insulin glargine followed by open-label metformin, (4) the glucagon-like peptide-1 receptor agonist (GLP-1RA) liraglutide plus open-label metformin. The primary clinical question RISE will address is: Are improvements in ß-cell function following 12 months of active treatment maintained for 3 months following the withdrawal of therapy? Secondary outcomes will assess durability of glucose tolerance following withdrawal of therapy, and whether biomarkers obtained in the fasting state predict parameters of ß-cell function, insulin sensitivity and glucose tolerance and the response to an intervention. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition |
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Intervention | Drug: Metformin Other Names: GlucophageDrug: Liraglutide Other Names: VictozaDrug: Glargine Other Names: Insulin glargine, Lantus |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 255 |
Estimated Completion Date | August 2017 |
Estimated Primary Completion Date | August 2017 |
Eligibility Criteria | Inclusion Criteria: 1. Fasting plasma glucose 95-125 mg/dl plus 2-hour glucose ≥140 mg/dl on 75 gm OGTT plus HbA1c ≥5.8 and ≤7.0%. There is no upper limit for the 2-hour glucose on OGTT. 2. Age 20-65 years 3. Body mass index (BMI) ≥25 kg/m2 but ≤40 kg/m2 4. Self-reported diabetes <1 year in duration 5. Drug naïve (no prior to oral glucose lowering agent(s), insulin or other injectable glucose lowering agents) Exclusion Criteria: 1. Underlying disease likely to limit life span and/or increase risk of intervention or an underlying condition that is likely to limit ability to participate in outcomes assessment 2. An underlying disease that affects glucose metabolism other than type 2 diabetes 3. Taking medications that affect glucose metabolism, or has an underlying condition that is likely to require such medications 4. Active infections 5. Renal disease (serum creatinine >1.4 mg/dl for men; >1.3 mg/dl for women) or serum potassium abnormality (<3.4 or >5.5 mmol/l) 6. Anemia (hemoglobin <11 g/dl in women, <12 g/dl in men) or known coagulopathy 7. Cardiovascular disease, including uncontrolled hypertension. Participants must be able to safely tolerate administration of intravenous fluids required during clamp studies. 8. History of conditions that may be precipitated or exacerbated by a study drug: 1. Pancreatitis 2. Serum alanine transaminase (ALT) more than 3 times the upper limit of normal 3. Excessive alcohol intake 4. Suboptimally treated thyroid disease 5. Medullary carcinoma of the thyroid or MEN-2 (in participant or a family history) 6. Hypertriglyceridemia (>400 mg/dl despite treatment) 9. Conditions or behaviors likely to affect the conduct of the RISE Study 1. Unable or unwilling to give informed consent 2. Unable to adequately communicate with clinic staff 3. Another household member is a participant or staff member in RISE 4. Current, recent or anticipated participation in another intervention research project that would interfere with any of the interventions/outcomes in RISE 5. Weight loss of >5% in past three months for any reason other than post-partum weight loss. Participants taking weight loss drugs or using preparations taken for intended weight loss are excluded. 6. Likely to move away from participating clinics in next two years 7. Women of childbearing potential who are unwilling to use adequate contraception 8. Current (or anticipated) pregnancy and lactation. 9. Major psychiatric disorder that, in the opinion of clinic staff, would impede the conduct of RISE 10. Additional conditions may serve as criteria for exclusion at the discretion of the local site. |
Gender | Both |
Ages | 20 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01779362 |
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Other Study ID Numbers | RISE Adult |
Has Data Monitoring Committee | Yes |
Information Provided By | RISE Study Group |
Study Sponsor | RISE Study Group |
Collaborators | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Investigators | Not Provided |
Verification Date | May 2013 |
Locations[ + expand ][ + ]
University of Chicago | Chicago, Illinois, United States, 60637 Contact: Abby Rue | 773-702-4295 | arue@medicine.bsd.uchicago.eduPrincipal Investigator: David Ehrmann, MD Recruiting |
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Indiana University | Indianapolis, Indiana, United States, 46202 Contact: Tammy Garrett, RN | 317-274-7679 | tjgarret@iupui.eduPrincipal Investigator: Kieren Mather, MD Recruiting |
VA Puget Sound Health Care System | Seattle, Washington, United States, 98108 Contact: Brenda Mongtomery, RN, MS | 206-768-5215 | bmont@u.washington.eduPrincipal Investigator: Steven Kahn, MB, ChB Recruiting |