Trial · NCT01779375

RISE Pediatric Medication Study

NCT01779375, Phase 3, Completed, RISE Study Group; results first posted 2018-10-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. RISE Pediatric Medication Study. Trials, record NCT01779375. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01779375

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Trial

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

Title: RISE Pediatric Medication Study
NCT number: NCT01779375
Status: Completed
Phases: Phase 3
Enrollment: 91 participants, actual
Lead sponsor: RISE Study Group
Conditions: Prediabetes, Type 2 Diabetes
Interventions: Metformin, Glargine
First posted: 2013-01-30
Last updated: 2023-04-14
Results first posted: 2018-10-09

Source ClinicalTrials.gov

Registered outcomes6

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	M/I	3-months after a medication washout	Clamp measure of insulin sensitivity
Secondary	ACPRg	3-months after a medication washout	First phase response
Secondary	ß-cell Function Measured by Hyperglycemic Clamp Techniques at M12	End of active intervention (Month 12).	Participants had 12-months of active therapy. Secondary results at the end of active intervention.
Secondary	Clamp Measure of Insulin Sensitivity	End of active intervention (Month 12)	Participants had 12-months of active therapy. Secondary results at the end of active intervention.
Other	OGTT Measures of ß-cell Function and Glucose Tolerance	After 12 months of active treatment, and 3 and 9 months of washout	Measures derived the OGTT at the end of the 12 month active intervention period, and following a 3-month and 9-month washout.

Source ClinicalTrials.gov

Outcomes6

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 able to have a M15 visit. 2 participants in the metformin alone arm decompensated at M12 and were unable to remain off treatment until M15. A sensitivity analysis including these 2 participants using 1/2 of the worst value among all other participants did not alter the results.	nmol/L	MEAN
PRIMARY	M/I	3-months after a medication washout	All participants with a Month 15 visit	x 10-5 mmol/kg/min per pmol/L	MEAN
SECONDARY	ACPRg	3-months after a medication washout	Primary analysis was on all participants able to have a M15 visit.	nmol/L	MEAN
SECONDARY	ß-cell Function Measured by Hyperglycemic Clamp Techniques at M12	End of active intervention (Month 12).	Secondary analysis was on all participants with a Month 12 visit.	nmol/L	MEAN
SECONDARY	Clamp Measure of Insulin Sensitivity	End of active intervention (Month 12)	Secondary analysis was on all participants with a Month 12 visit.	x 10-5 mmol/kg/min per pmol/L	MEAN
OTHER_PRE_SPECIFIED	OGTT Measures of ß-cell Function and Glucose Tolerance	After 12 months of active treatment, and 3 and 9 months of washout

Source ClinicalTrials.gov

Results by group16

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	4.82	95% Confidence Interval 2.07 to 11.23	nmol/L
ß-cell Response Measured by Hyperglycemic Clamp	Glargine Followed by Metformin	Steady State C-peptide	4.18	95% Confidence Interval 1.74 to 10.08	nmol/L
ß-cell Response Measured by Hyperglycemic Clamp	Metformin Alone	ACPRmax	6.92	95% Confidence Interval 2.81 to 17.03	nmol/L
ß-cell Response Measured by Hyperglycemic Clamp	Glargine Followed by Metformin	ACPRmax	5.95	95% Confidence Interval 2.17 to 16.37	nmol/L
M/I	Metformin Alone		1.48	95% Confidence Interval 0.29 to 7.63	x 10-5 mmol/kg/min per pmol/L
M/I	Glargine Followed by Metformin		1.70	95% Confidence Interval 0.25 to 11.54	x 10-5 mmol/kg/min per pmol/L
ACPRg	Metformin Alone		1.11	95% Confidence Interval 0.14 to 8.56	nmol/L
ACPRg	Glargine Followed by Metformin		1.12	95% Confidence Interval 0.15 to 8.35	nmol/L
ß-cell Function Measured by Hyperglycemic Clamp Techniques at M12	Metformin Alone	Steady State C-peptide	4.78	95% Confidence Interval 2.09 to 10.94	nmol/L
ß-cell Function Measured by Hyperglycemic Clamp Techniques at M12	Glargine Followed by Metformin	Steady State C-peptide	4.37	95% Confidence Interval 1.75 to 10.94	nmol/L

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Metformin Alone	47
Overall Study	STARTED	Glargine Followed by Metformin	44
Overall Study	COMPLETED	Metformin Alone	45
Overall Study	COMPLETED	Glargine Followed by Metformin	41
Overall Study	NOT COMPLETED	Metformin Alone	2
Overall Study	NOT COMPLETED	Glargine Followed by Metformin	3

Source ClinicalTrials.gov

Adverse events20

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	Low blood sugar	Endocrine disorders	Metformin Alone	0	47
other	Low blood sugar	Endocrine disorders	Glargine Followed by Metformin	16	44
other	Skin rash	Skin and subcutaneous tissue disorders	Metformin Alone	6	47
other	Skin rash	Skin and subcutaneous tissue disorders	Glargine Followed by Metformin	6	44
other	GI Discomfort	Gastrointestinal disorders	Metformin Alone	16	47
other	GI Discomfort	Gastrointestinal disorders	Glargine Followed by Metformin	17	44
other	Polyuria or polydipsia	Endocrine disorders	Metformin Alone	11	47
other	Polyuria or polydipsia	Endocrine disorders	Glargine Followed by Metformin	11	44
serious	Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Metformin Alone	0	47	0
serious	Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Glargine Followed by Metformin	1	44	1

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Metformin Alone	0	47
Total, all-cause mortality	Glargine Followed by Metformin	0	44
Total, other adverse events	Metformin Alone	30	47
Total, other adverse events	Glargine Followed by Metformin	30	44
Total, serious adverse events	Metformin Alone	5	47
Total, serious adverse events	Glargine Followed by Metformin	2	44

Source ClinicalTrials.gov

Papers14

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
24194506	BACKGROUND	PubMed
28493515	BACKGROUND	PubMed
29941497	BACKGROUND	PubMed
29941498	BACKGROUND	PubMed
29941500	RESULT	PubMed
31178433	DERIVED	PubMed
31301210	DERIVED	PubMed
32985775	DERIVED	PubMed
33436401	DERIVED	PubMed
34131047	DERIVED	PubMed

1 to 10 of 14

See all 14 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 comparisons2

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

Comparison	Source
Metformin Alone vs Glargine Followed by Metformin: deaths from any cause	Trial comparisons
Metformin Alone vs Glargine Followed by Metformin: serious adverse events	Trial comparisons

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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