Study S002086

Restoring Insulin Secretion Adult Medication Study

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT01779362
Acronym: RISE Adult
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 267
Start: 2013-04
Primary completion: 2019-02
Lead sponsor: RISE Study Group
Conditions: Prediabetes; Type 2 Diabetes
Interventions: DRUG:Metformin; DRUG:Liraglutide; DRUG:Glargine; DRUG:Placebo
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: NIH:5U01DK094406-02

Registered primary outcomes

ß-cell Response Measured by Hyperglycemic Clamp [3-months after medication washout (Month 15)]
Insulin Sensitivity, M/I [3-months after a medication washout]

Linked records (6)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0026310	Weight loss and β-cell responses following gastric banding or pharmacotherapy in adults with impaired glucose tolerance or type 2 diabetes: a randomized trial. Utzschneider KM, Obesity (Silver Spring, Md.)	2022	Randomized trial	PMID 35894078 DOI	cites ClinicalTrials.gov:NCT01779362; registry reference DERIVED:35894078
R0027303	Effect of Medical and Surgical Interventions on α-Cell Function in Dysglycemic Youth and Adults in the RISE Study. Kahn SE, Diabetes care	2021	Randomized trial	PMID 34135015 DOI	cites ClinicalTrials.gov:NCT01779362; registry reference DERIVED:34135015
R0027591	Baseline Predictors of Glycemic Worsening in Youth and Adults With Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes in the Restoring Insulin Secretion (RISE) Study. Sam S, Diabetes care	2021	Randomized trial	PMID 34131048 DOI	cites ClinicalTrials.gov:NCT01779362; registry reference DERIVED:34131048
R0024857	Metformin monotherapy for adults with type 2 diabetes mellitus. Gnesin F, The Cochrane database of systematic reviews	2020	Systematic review	PMID 32501595 DOI	cites ClinicalTrials.gov:NCT01779362; registry reference DERIVED:32501595
R0025599	Lack of Durable Improvements in β-Cell Function Following Withdrawal of Pharmacological Interventions in Adults With Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes. RISE Consortium, Diabetes care	2019	Randomized trial	PMID 31178434 DOI	cites ClinicalTrials.gov:NCT01779362; registry reference DERIVED:31178434
R0028096	Restoring Insulin Secretion (RISE): design of studies of β-cell preservation in prediabetes and early type 2 diabetes across the life span. RISE Consortium, Diabetes care	2014	Randomized trial	PMID 24194506 DOI	cites ClinicalTrials.gov:NCT01779362; registry reference BACKGROUND:24194506