Trial · NCT01779362

RISE Adult Medication Study

NCT01779362, Phase 3, Completed, RISE Study Group; results first posted 2023-05-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. RISE Adult Medication Study. Trials, record NCT01779362. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01779362

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: RISE Adult Medication Study
NCT number: NCT01779362
Status: Completed
Phases: Phase 3
Enrollment: 267 participants, actual
Lead sponsor: RISE Study Group
Conditions: Prediabetes, Type 2 Diabetes
Interventions: Metformin, Liraglutide, Glargine, Placebo
First posted: 2013-01-30
Last updated: 2023-05-11
Results first posted: 2023-05-11

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	ß-cell Response Measured by Hyperglycemic Clamp	3-months after medication washout (Month 15)	Clamp measures of ß-cell response, co-primary outcomes
Primary	Insulin Sensitivity, M/I	3-months after a medication washout	Clamp measure of insulin sensitivity
Secondary	ACPRg	3-months after a medication washout	First phase response from the hyperglycemic clamp
Secondary	ß-cell Function Measured by Hyperglycemic Clamp Techniques at M12	Secondary analysis was on all participants with a Month 12 visit.	Participants had 12-months of active therapy. Secondary results at the end of active intervention.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	ß-cell Response Measured by Hyperglycemic Clamp	3-months after medication washout (Month 15)	Primary analysis was on all participants who attended their M15 visit.	nmol/L	GEOMETRIC_MEAN
PRIMARY	Insulin Sensitivity, M/I	3-months after a medication washout	All participants with a Month 15 visit	x 10-5 mmol/kg/min per pmol/L	GEOMETRIC_MEAN
SECONDARY	ACPRg	3-months after a medication washout	Analysis was on all participants able to have a M15 visit.	nmol/L	GEOMETRIC_MEAN
SECONDARY	ß-cell Function Measured by Hyperglycemic Clamp Techniques at M12	Secondary analysis was on all participants with a Month 12 visit.	Secondary analysis was on all participants with a Month 12 visit.	nmol/L	GEOMETRIC_MEAN

Source ClinicalTrials.gov

Results by group28

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
ß-cell Response Measured by Hyperglycemic Clamp	Metformin Alone	Steady State C-peptide	3.65	95% Confidence Interval 1.94 to 6.87	nmol/L
ß-cell Response Measured by Hyperglycemic Clamp	Glargine Followed by Metformin	Steady State C-peptide	3.58	95% Confidence Interval 1.68 to 8.33	nmol/L
ß-cell Response Measured by Hyperglycemic Clamp	Placebo	Steady State C-peptide	3.60	95% Confidence Interval 1.72 to 7.53	nmol/L
ß-cell Response Measured by Hyperglycemic Clamp	Liraglutide + Metformin	Steady State C-peptide	3.73	95% Confidence Interval 1.87 to 7.44	nmol/L
ß-cell Response Measured by Hyperglycemic Clamp	Metformin Alone	ACPRmax	4.61	95% Confidence Interval 2.00 to 10.66	nmol/L
ß-cell Response Measured by Hyperglycemic Clamp	Glargine Followed by Metformin	ACPRmax	4.32	95% Confidence Interval 1.58 to 11.80	nmol/L
ß-cell Response Measured by Hyperglycemic Clamp	Placebo	ACPRmax	4.45	95% Confidence Interval 1.56 to 12.71	nmol/L
ß-cell Response Measured by Hyperglycemic Clamp	Liraglutide + Metformin	ACPRmax	4.58	95% Confidence Interval 2.21 to 9.48	nmol/L
Insulin Sensitivity, M/I	Metformin Alone		3.53	95% Confidence Interval 0.67 to 18.49	x 10-5 mmol/kg/min per pmol/L
Insulin Sensitivity, M/I	Glargine Followed by Metformin		3.38	95% Confidence Interval 0.61 to 18.84	x 10-5 mmol/kg/min per pmol/L

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Metformin Alone	65
Overall Study	STARTED	Glargine Followed by Metformin	67
Overall Study	STARTED	Placebo	67
Overall Study	STARTED	Liraglutide + Metformin	68
Overall Study	COMPLETED	Metformin Alone	56
Overall Study	COMPLETED	Glargine Followed by Metformin	65
Overall Study	COMPLETED	Placebo	58
Overall Study	COMPLETED	Liraglutide + Metformin	53
Overall Study	NOT COMPLETED	Metformin Alone	9
Overall Study	NOT COMPLETED	Glargine Followed by Metformin	2

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events80

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Any low blood sugar	Endocrine disorders	Metformin Alone	3	65	3
other	Any low blood sugar	Endocrine disorders	Glargine Followed by Metformin	8	67	8
other	Any low blood sugar	Endocrine disorders	Placebo	5	67	5
other	Any low blood sugar	Endocrine disorders	Liraglutide + Metformin	1	68	1
other	Skin rash	Skin and subcutaneous tissue disorders	Metformin Alone	3	65	3
other	Skin rash	Skin and subcutaneous tissue disorders	Glargine Followed by Metformin	6	67	6
other	Skin rash	Skin and subcutaneous tissue disorders	Placebo	4	67	4
other	Skin rash	Skin and subcutaneous tissue disorders	Liraglutide + Metformin	1	68	1
other	GI Symptoms	Gastrointestinal disorders	Metformin Alone	23	65	23
other	GI Symptoms	Gastrointestinal disorders	Glargine Followed by Metformin	12	67	12

1 to 10 of 80Source ClinicalTrials.gov

See all 80 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Metformin Alone	0	65
Total, all-cause mortality	Glargine Followed by Metformin	0	67
Total, all-cause mortality	Placebo	0	67
Total, all-cause mortality	Liraglutide + Metformin	0	68
Total, other adverse events	Metformin Alone	29	65
Total, other adverse events	Glargine Followed by Metformin	28	67
Total, other adverse events	Placebo	23	67
Total, other adverse events	Liraglutide + Metformin	30	68
Total, serious adverse events	Metformin Alone	5	65
Total, serious adverse events	Glargine Followed by Metformin	2	67

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers15

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
24194506	BACKGROUND	PubMed
28493515	BACKGROUND	PubMed
29941497	DERIVED	PubMed
29941498	DERIVED	PubMed
31178433	DERIVED	PubMed
31178434	DERIVED	PubMed
31301210	DERIVED	PubMed
32501595	DERIVED	PubMed
33436401	DERIVED	PubMed
34131047	DERIVED	PubMed

1 to 10 of 15

See all 15 papers

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01DK094406	Optimizing Recovery and Preservation of Endogenous Insulin Secretion	KAHN, STEVEN EMANUEL	SEATTLE INST FOR BIOMEDICAL/CLINICAL RES	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2011 to 2015

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

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