Phase 3
N=267
RISE Adult Medication Study
Prediabetes · Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT01779362 ↗Enrolled (actual)
267
Serious AEs
6.4%
Results posted
May 2023
Primary outcome: Primary: ß-cell Response Measured by Hyperglycemic Clamp — 3.65; 3.58; 3.60; 3.73 nmol/L — p=>0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Metformin (Drug); Liraglutide (Drug); Glargine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- RISE Study Group
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ß-cell Response Measured by Hyperglycemic Clamp |
3.65; 3.58; 3.60; 3.73; 4.61; 4.32 | >0.05 |
| PRIMARY Insulin Sensitivity, M/I |
3.53; 3.38; 3.63; 3.49 | >0.05 |
| SECONDARY ACPRg |
1.68; 1.68; 1.68; 1.68 | >0.05 |
| SECONDARY ß-cell Function Measured by Hyperglycemic Clamp Techniques at M12 |
1.93; 1.88; 1.69; 2.68; 11.7; 11.6 | <0.001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- 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 1.4 mg/dl for men; >1.3 mg/dl for women) or serum potassium abnormality ( 5.5 mmol/l)
- Anemia (hemoglobin 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.
Data sourced from ClinicalTrials.gov (NCT01779362). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.