RISE Adult Medication Study

Part of paid clinical trials in Chicago, Illinois.

Sponsor
RISE Study Group
Study ID
NCT01779362
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Metformin — DRUG
    Titrated to 1000 mg BID
  • Liraglutide — DRUG
    Titrated to 1.8 mg/day
  • Glargine — DRUG
    Titrated to target fasting glucose \<90 mg/dl
  • Placebo — DRUG
    Matching to metformin 1000 mg BI

Study Details

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 Dates

Start date
Apr 30, 2013
Status verified
Aug 2018
Primary completion
Feb 28, 2019
Completion
Aug 31, 2019

Study Design

Enrollment
267 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Metformin alone
    Metformin will be titrated to the maximum dose tolerated (up to 2000 mg/day). Participants randomized to the metformin-alone arm will be blinded to treatment.
  • Active Comparator: Glargine followed by Metformin
    Basal insulin glargine for 3 months titrated to achieve a morning fasting blood glucose of 80-90 mg/dl, followed by open-label metformin (titrated up to 2000 mg/day) for 9 months.
  • Placebo Comparator: Placebo
    Placebo - masked to metformin-alone. Placebo will be titrated to the maximum number of tablets equivalent to maximum dose of metformin.
  • Active Comparator: Liraglutide + Metformin
    Liraglutide + open-label Metformin. Liraglutide will be titrated to the maximum dose tolerated (up to 1.8 mg/day) after which metformin will be titrated to the maximum dose tolerated (up to 2000 mg/day).

Primary Outcome Measure

ß-cell Response Measured by Hyperglycemic Clamp [ Time Frame: 3-months after medication washout (Month 15) ]

Locations (4)

FacilityCityStateZIPSite coordinators
Jesse Brown VA Medical CenterChicagoIllinois60612-
University of ChicagoChicagoIllinois60637-
Indiana UniversityIndianapolisIndiana46202-
VA Puget Sound Health Care SystemSeattleWashington98108-

Find similar trials in Chicago, IL

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Jesse Brown VA Medical Center· Chicago, ILUniversity of Chicago· Chicago, ILIndiana University· Indianapolis, INVA Puget Sound Health Care System· Seattle, WA

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