RISE Adult Medication Study

Completed · Phase 3 · Has a placebo group

Conditions studied: Prediabetes, Type 2 Diabetes

In brief

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.

Key facts

Study ID: NCT01779362
Run by: RISE Study Group
People needed: 267
Starts: 2013-04-01
Expected to finish: 2019-08-01
Last updated by the study team: 2023-05-11

Who can join

Age: 20 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Fasting plasma glucose 95-125 mg/dl plus 2-hour glucose ≥140 mg/dl on 75 gm OGTT plus HbA1c ≤7.0%. There is no upper limit for the 2-hour glucose on OGTT.
Age 20-65 years
Body mass index (BMI) ≥25 kg/m2 but ≤50 kg/m2
Self-reported diabetes <1 year in duration
Drug naïve (no prior to oral glucose lowering agent(s), insulin or other injectable glucose lowering agents)

You may not qualify if…

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
An underlying disease that affects glucose metabolism other than type 2 diabetes
Taking medications that affect glucose metabolism, or has an underlying condition that is likely to require such medications
Active infections
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)
Anemia (hemoglobin <11 g/dl in women, <12 g/dl in men) or known coagulopathy
Cardiovascular disease, including uncontrolled hypertension. Participants must be able to safely tolerate administration of intravenous fluids required during clamp studies.
History of conditions that may be precipitated or exacerbated by a study drug:
Pancreatitis
Serum alanine transaminase (ALT) more than 3 times the upper limit of normal
Excessive alcohol intake
Suboptimally treated thyroid disease
Medullary carcinoma of the thyroid or MEN-2 (in participant or a family history)
Hypertriglyceridemia (>400 mg/dl despite treatment)
Conditions or behaviors likely to affect the conduct of the RISE Study
Unable or unwilling to give informed consent
Unable to adequately communicate with clinic staff
Another household member is a participant or staff member in RISE
Current, recent or anticipated participation in another intervention research project that would interfere with any of the interventions/outcomes in RISE
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.
Likely to move away from participating clinics in next two years
Women of childbearing potential who are unwilling to use adequate contraception
Current (or anticipated) pregnancy and lactation.
Major psychiatric disorder that, in the opinion of clinic staff, would impede the conduct of RISE
Additional conditions may serve as criteria for exclusion at the discretion of the local site.

Where it is running

Jesse Brown VA Medical Center — Chicago, Illinois, United States
University of Chicago — Chicago, Illinois, United States
Indiana University — Indianapolis, Indiana, United States
VA Puget Sound Health Care System — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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