PrediabetesPhase 3RISE PedsNCT01779375

RISE Pediatric Medication Study

A Phase 3 study testing Metformin and Glargine in people with Prediabetes and Type 2 Diabetes, run by RISE Study Group at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 10 to 19 yearsHealthy volunteers can take part
Conditions the study is for: Prediabetes, Type 2 Diabetes
What is being tested?: Metformin and Glargine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 91 participants
Where: 4 sitesUnited States
Study dates: 16 Jun 2013to Apr 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 to 19 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Fasting plasma glucose ≥90 mg/dl plus 2-hour glucose ≥140 mg/dl on 75 gm OGTT plus laboratory-based HbA1c ≤8.0% if treatment naïve. There is no upper limit for the 2-hour glucose on OGTT. In those taking metformin laboratory-based HbA1c must be ≤7.5% if on metformin for <3 months and ≤7.0% if on metformin for 3-6 months.
Age 10-19 years
Pubertal development Tanner stage >1 as defined by breast stage >1 in girls, and testes >3 cc's in boys.
Body mass index (BMI) ≥85th percentile but ≤50 kg/m2
Self-reported diabetes <6 months in duration
Treatment with metformin for <6 months preceding screening

Who cannot join

Underlying disease likely to limit life span and/or increase risk of intervention or an underlying condition that is likely to limit ability to participate in outcomes assessment
An underlying disease that affects glucose metabolism other than type 2 diabetes mellitus
Taking medications that affect glucose metabolism, or has an underlying condition that is likely to require such medications
Treatment with insulin for >1 week preceding screening
Active infections
Renal disease (serum creatinine >1.2 mg/dl) or serum potassium abnormality (<3.4 or >5.5 mmol/l)

Show all 25Show fewer

Anemia (hemoglobin <11 g/dl in girls, <12 g/dl in boys) or known coagulopathy
Cardiovascular disease, including uncontrolled hypertension defined as average systolic or diastolic blood pressure > 99 percentile for age or >135/90, despite adequately prescribed antihypertensive medications. Participants must be able to safely tolerate administration of intravenous fluids required during clamp studies.
History of conditions that may be precipitated or exacerbated by a study drug:
Serum alanine transaminase (ALT) more than 3 times the upper limit of normal
Excessive alcohol intake
Sub-optimally treated thyroid disease
Conditions or behaviors likely to affect the conduct of the RISE Study
Participant and/or parents unable or unwilling to give informed consent
Participant and/or parents 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% of body weight in the past 3 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 2 years
Current (or anticipated) pregnancy and lactation.
A pregnancy that was completed less than 6 months prior to screening.
Breast feeding within 6 months prior to screening.
Women of childbearing potential who are unwilling to use adequate contraception
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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Childrens Hospital Colorado
Denver, Colorado, 80045
Indiana University
Indianapolis, Indiana, 46202
Yale School of Medicine Pediatric Obesity and Type 2 Diabetes Clinic
New Haven, Connecticut, 06511
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224

Other trials in United States

About this study

Official title: Restoring Insulin Secretion Pediatric Medication Study

The RISE Pediatric Medication Study is a 2-arm, 4-center, clinical trial of children 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. Pediatric participants (ages 10-19) will be randomized to one of the following treatment regimens: (1) metformin alone or (2) early intensive treatment with basal insulin glargine followed by 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.

Conditions: Prediabetes, Type 2 Diabetes
Being tested: Metformin, Glargine
Keywords: Children, Pediatric
Medical subject headings: Prediabetic State, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MetforminDrug
Also called Glucophage
GlargineDrug
Also called Insulin glargine, Lantus

Study groups in NCT01779375
Study group	Role	What they receive
Metformin alone	Active comparator	Metformin will be titrated to the maximum dose tolerated (up to 2000 mg/day). Receives: Drug: Metformin
Glargine followed by Metformin	Active comparator	Basal insulin glargine for 3 months titrated to achieve a morning fasting blood glucose of 85-95 mg/dl, followed by metformin (titrated up to 2000 mg/day) for 9 months. Receives: Drug: Metformin; Drug: Glargine

What is being measured

The primary outcome is the main question the study is designed to answer.

ß-cell Response Measured by Hyperglycemic Clamp
Clamp measures of ß-cell response, co-primary outcomes
Measured: 3-months after medication washout (Month 15)
M/I
Clamp measure of insulin sensitivity
Measured: 3-months after a medication washout

Secondary outcomes (3)

ACPRg
First phase response
Measured: 3-months after a medication washout
ß-cell Function Measured by Hyperglycemic Clamp Techniques at M12
Participants had 12-months of active therapy. Secondary results at the end of active intervention.
Measured: End of active intervention (Month 12).
Clamp Measure of Insulin Sensitivity
Participants had 12-months of active therapy. Secondary results at the end of active intervention.
Measured: End of active intervention (Month 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jun 2013Apr 2018

First posted30 Jan 2013 (estimated)
Study start16 Jun 2013
Primary completion12 Jul 2017
Study completionApr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (14)Papers the sponsor has linked to this study.
Other trials for PrediabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01779375
Sponsor's protocol ID: RISE Pediatric
Other IDs: 5U01DK094406-02
Acronym: RISE Peds
Status last verified: Apr 2023
First submitted: 28 Jan 2013
Last updated: 14 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Will share all research data via the NIDDK repository 2 years after final patient visit from the RISE consortium in \~2020. Data may be obtained from the repository directly.

Publications

RISE Consortium. Metabolic Contrasts Between Youth and Adults With Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes: II. Observations Using the Oral Glucose Tolerance Test. Diabetes Care. 2018 Aug;41(8):1707-1716. doi: 10.2337/dc18-0243. Epub 2018 Jun 25.
PubMed 29941498
RISE Consortium. Metabolic Contrasts Between Youth and Adults With Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes: I. Observations Using the Hyperglycemic Clamp. Diabetes Care. 2018 Aug;41(8):1696-1706. doi: 10.2337/dc18-0244. Epub 2018 Jun 25.
PubMed 29941497
Hannon TS, Kahn SE, Utzschneider KM, Buchanan TA, Nadeau KJ, Zeitler PS, Ehrmann DA, Arslanian SA, Caprio S, Edelstein SL, Savage PJ, Mather KJ; RISE Consortium. Review of methods for measuring beta-cell function: Design considerations from the Restoring Insulin Secretion (RISE) Consortium. Diabetes Obes Metab. 2018 Jan;20(1):14-24. doi: 10.1111/dom.13005. Epub 2017 Jun 22.
PubMed 28493515
RISE Consortium. Restoring Insulin Secretion (RISE): design of studies of beta-cell preservation in prediabetes and early type 2 diabetes across the life span. Diabetes Care. 2014;37(3):780-8. doi: 10.2337/dc13-1879. Epub 2013 Nov 5.
PubMed 24194506
RISE Consortium. Impact of Insulin and Metformin Versus Metformin Alone on beta-Cell Function in Youth With Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes. Diabetes Care. 2018 Aug;41(8):1717-1725. doi: 10.2337/dc18-0787. Epub 2018 Jun 25.
PubMed 29941500
Tjaden AH, Edelstein SL, Arslanian S, Barengolts E, Caprio S, Cree-Green M, Lteif A, Mather KJ, Savoye M, Xiang AH, Kahn SE. Reproducibility of Glycemic Measures Among Dysglycemic Youth and Adults in the RISE Study. J Clin Endocrinol Metab. 2023 Sep 18;108(10):e1125-e1133. doi: 10.1210/clinem/dgad135.
PubMed 36938582
Utzschneider KM, Tripputi MT, Kozedub A, Barengolts E, Caprio S, Cree-Green M, Edelstein SL, El Ghormli L, Hannon TS, Mather KJ, Palmer J, Nadeau KJ; RISE Consortium. Differential loss of beta-cell function in youth vs. adults following treatment withdrawal in the Restoring Insulin Secretion (RISE) study. Diabetes Res Clin Pract. 2021 Aug;178:108948. doi: 10.1016/j.diabres.2021.108948. Epub 2021 Jul 15.
PubMed 34274407
Kahn SE, Edelstein SL, Arslanian SA, Barengolts E, Caprio S, Ehrmann DA, Hannon TS, Marcovina S, Mather KJ, Nadeau KJ, Utzschneider KM, Xiang AH, Buchanan TA; RISE Consortium; Rise Consortium Investigators:. Effect of Medical and Surgical Interventions on alpha-Cell Function in Dysglycemic Youth and Adults in the RISE Study. Diabetes Care. 2021 Sep;44(9):1948-1960. doi: 10.2337/dc21-0461. Epub 2021 Jun 16.
PubMed 34135015
Sam S, Edelstein SL, Arslanian SA, Barengolts E, Buchanan TA, Caprio S, Ehrmann DA, Hannon TS, Tjaden AH, Kahn SE, Mather KJ, Tripputi M, Utzschneider KM, Xiang AH, Nadeau KJ; RISE Consortium; RISE Consortium Investigators. 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. Diabetes Care. 2021 Sep;44(9):1938-1947. doi: 10.2337/dc21-0027. Epub 2021 Jun 15.
PubMed 34131048
Kahn SE, Mather KJ, Arslanian SA, Barengolts E, Buchanan TA, Caprio S, Ehrmann DA, Hannon TS, Marcovina S, Nadeau KJ, Utzschneider KM, Xiang AH, Edelstein SL; RISE Consortium; Rise Consortium Investigators:. Hyperglucagonemia Does Not Explain the beta-Cell Hyperresponsiveness and Insulin Resistance in Dysglycemic Youth Compared With Adults: Lessons From the RISE Study. Diabetes Care. 2021 Sep;44(9):1961-1969. doi: 10.2337/dc21-0460. Epub 2021 Jun 15.
PubMed 34131047
Arslanian SA, El Ghormli L, Kim JY, Tjaden AH, Barengolts E, Caprio S, Hannon TS, Mather KJ, Nadeau KJ, Utzschneider KM, Kahn SE; RISE Consortium. OGTT Glucose Response Curves, Insulin Sensitivity, and beta-Cell Function in RISE: Comparison Between Youth and Adults at Randomization and in Response to Interventions to Preserve beta-Cell Function. Diabetes Care. 2021 Mar;44(3):817-825. doi: 10.2337/dc20-2134. Epub 2021 Jan 12.
PubMed 33436401
Hannon TS, Edelstein SL, Arslanian SA, Caprio S, Zeitler PS, Buchanan TA, Ehrmann DA, Mather KJ, Tripputi M, Kahn SE, Nadeau KJ; RISE Consortium. Withdrawal of medications leads to worsening of OGTT parameters in youth with impaired glucose tolerance or recently-diagnosed type 2 diabetes. Pediatr Diabetes. 2020 Dec;21(8):1437-1446. doi: 10.1111/pedi.13129. Epub 2020 Oct 13.
PubMed 32985775
RISE Consortium. Obesity and insulin sensitivity effects on cardiovascular risk factors: Comparisons of obese dysglycemic youth and adults. Pediatr Diabetes. 2019 Nov;20(7):849-860. doi: 10.1111/pedi.12883. Epub 2019 Jul 29.
PubMed 31301210
RISE Consortium; RISE Consortium Investigators. Effects of Treatment of Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes With Metformin Alone or in Combination With Insulin Glargine on beta-Cell Function: Comparison of Responses In Youth And Adults. Diabetes. 2019 Aug;68(8):1670-1680. doi: 10.2337/db19-0299. Epub 2019 Jun 9.
PubMed 31178433

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Restoring Insulin Secretion Pediatric Medication Study
ClinicalTrials.gov ID: NCT01779375
Acronym / sponsor ID: RISE Peds / RISE Pediatric
Conditions: Prediabetes, Type 2 Diabetes
Keywords: Children, Pediatric
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: RISE Study GroupResearch network
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 16 Jun 2013 (actual)
Primary completion: 12 Jul 2017 (actual)
Study completion: Apr 2018 (actual)
First posted: 30 Jan 2013 (estimated)
Results: Posted 9 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Metformin alone	Active comparator	Drug: MetforminMetformin will be titrated to the maximum dose tolerated (up to 2000 mg/day).
Glargine followed by Metformin	Active comparator	Drug: Metformin, Drug: GlargineBasal insulin glargine for 3 months titrated to achieve a morning fasting blood glucose of 85-95 mg/dl, followed by metformin (titrated up to 2000 mg/day) for 9 months.

Who may qualify

Ages: 10 to 19 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

Fasting plasma glucose ≥90 mg/dl plus 2-hour glucose ≥140 mg/dl on 75 gm OGTT plus laboratory-based HbA1c ≤8.0% if treatment naïve. There is no upper limit for the 2-hour glucose on OGTT. In those taking metformin laboratory-based HbA1c must be ≤7.5% if on metformin for <3 months and ≤7.0% if on metformin for 3-6 months.
Age 10-19 years
Pubertal development Tanner stage >1 as defined by breast stage >1 in girls, and testes >3 cc's in boys.
Body mass index (BMI) ≥85th percentile but ≤50 kg/m2
Self-reported diabetes <6 months in duration

Key exclusion criteria (25 listed)

Underlying disease likely to limit life span and/or increase risk of intervention or an underlying condition that is likely to limit ability to participate in outcomes assessment
An underlying disease that affects glucose metabolism other than type 2 diabetes mellitus
Taking medications that affect glucose metabolism, or has an underlying condition that is likely to require such medications
Treatment with insulin for >1 week preceding screening
Active infections

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MetforminAlso: Glucophage	Drug	Glargine followed by Metformin, Metformin alone
GlargineAlso: Insulin glargine, Lantus	Drug	Glargine followed by Metformin

Primary outcome

ß-cell Response Measured by Hyperglycemic Clamp
Time frame: 3-months after medication washout (Month 15)
Clamp measures of ß-cell response, co-primary outcomes
M/I
Time frame: 3-months after a medication washout
Clamp measure of insulin sensitivity

3 secondary outcomes

ACPRg
Time frame: 3-months after a medication washout
ß-cell Function Measured by Hyperglycemic Clamp Techniques at M12
Time frame: End of active intervention (Month 12).
Clamp Measure of Insulin Sensitivity
Time frame: End of active intervention (Month 12)

Results and safety

Results posted to the registry on 9 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Metformin Alone	47	45
Glargine Followed by Metformin	44	41

Primary outcome: ß-cell Response Measured by Hyperglycemic Clamp

Time frame: 3-months after medication washout (Month 15). Mean (95% Confidence Interval). Unit: nmol/L

Measure	Metformin Alone n = 43	Glargine Followed by Metformin n = 41
Steady State C-peptide	4.82 (2.07 to 11.23)	4.18 (1.74 to 10.08)
ACPRmax	6.92 (2.81 to 17.03)	5.95 (2.17 to 16.37)

Metformin Alone vs Glargine Followed by Metformin: p >0.05, Regression, Linear

Population analysed: 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.

Primary outcome: M/I

Time frame: 3-months after a medication washout. Mean (95% Confidence Interval). Unit: x 10-5 mmol/kg/min per pmol/L

Measure	Metformin Alone n = 43	Glargine Followed by Metformin n = 41
Value	1.48 (0.29 to 7.63)	1.70 (0.25 to 11.54)

Metformin Alone vs Glargine Followed by Metformin: p >0.05, Regression, Linear

Population analysed: All participants with a Month 15 visit

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the 21 month study period. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Metformin Alone	5 of 47 (10.6%)	30 of 47 (63.8%)	0 of 47
Glargine Followed by Metformin	2 of 44 (4.5%)	30 of 44 (68.2%)	0 of 44

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29941498RISE Consortium. Metabolic Contrasts Between Youth and Adults With Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes: II. Observations Using the Oral Glucose Tolerance Test. Diabetes Care. 2018 Aug;41(8):1707-1716. doi: 10.2337/dc18-0243. Epub 2018 Jun 25.
Background: PubMed 29941497RISE Consortium. Metabolic Contrasts Between Youth and Adults With Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes: I. Observations Using the Hyperglycemic Clamp. Diabetes Care. 2018 Aug;41(8):1696-1706. doi: 10.2337/dc18-0244. Epub 2018 Jun 25.
Background: PubMed 28493515Hannon TS, Kahn SE, Utzschneider KM, Buchanan TA, Nadeau KJ, Zeitler PS, Ehrmann DA, Arslanian SA, Caprio S, Edelstein SL, Savage PJ, Mather KJ; RISE Consortium. Review of methods for measuring beta-cell function: Design considerations from the Restoring Insulin Secretion (RISE) Consortium. Diabetes Obes Metab. 2018 Jan;20(1):14-24. doi: 10.1111/dom.13005. Epub 2017 Jun 22.
Background: PubMed 24194506RISE Consortium. Restoring Insulin Secretion (RISE): design of studies of beta-cell preservation in prediabetes and early type 2 diabetes across the life span. Diabetes Care. 2014;37(3):780-8. doi: 10.2337/dc13-1879. Epub 2013 Nov 5.
Results publication: PubMed 29941500RISE Consortium. Impact of Insulin and Metformin Versus Metformin Alone on beta-Cell Function in Youth With Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes. Diabetes Care. 2018 Aug;41(8):1717-1725. doi: 10.2337/dc18-0787. Epub 2018 Jun 25.
Derived from this study: PubMed 36938582Tjaden AH, Edelstein SL, Arslanian S, Barengolts E, Caprio S, Cree-Green M, Lteif A, Mather KJ, Savoye M, Xiang AH, Kahn SE. Reproducibility of Glycemic Measures Among Dysglycemic Youth and Adults in the RISE Study. J Clin Endocrinol Metab. 2023 Sep 18;108(10):e1125-e1133. doi: 10.1210/clinem/dgad135.
Derived from this study: PubMed 34274407Utzschneider KM, Tripputi MT, Kozedub A, Barengolts E, Caprio S, Cree-Green M, Edelstein SL, El Ghormli L, Hannon TS, Mather KJ, Palmer J, Nadeau KJ; RISE Consortium. Differential loss of beta-cell function in youth vs. adults following treatment withdrawal in the Restoring Insulin Secretion (RISE) study. Diabetes Res Clin Pract. 2021 Aug;178:108948. doi: 10.1016/j.diabres.2021.108948. Epub 2021 Jul 15.
Derived from this study: PubMed 34135015Kahn SE, Edelstein SL, Arslanian SA, Barengolts E, Caprio S, Ehrmann DA, Hannon TS, Marcovina S, Mather KJ, Nadeau KJ, Utzschneider KM, Xiang AH, Buchanan TA; RISE Consortium; Rise Consortium Investigators:. Effect of Medical and Surgical Interventions on alpha-Cell Function in Dysglycemic Youth and Adults in the RISE Study. Diabetes Care. 2021 Sep;44(9):1948-1960. doi: 10.2337/dc21-0461. Epub 2021 Jun 16.
Derived from this study: PubMed 34131048Sam S, Edelstein SL, Arslanian SA, Barengolts E, Buchanan TA, Caprio S, Ehrmann DA, Hannon TS, Tjaden AH, Kahn SE, Mather KJ, Tripputi M, Utzschneider KM, Xiang AH, Nadeau KJ; RISE Consortium; RISE Consortium Investigators. 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. Diabetes Care. 2021 Sep;44(9):1938-1947. doi: 10.2337/dc21-0027. Epub 2021 Jun 15.
Derived from this study: PubMed 34131047Kahn SE, Mather KJ, Arslanian SA, Barengolts E, Buchanan TA, Caprio S, Ehrmann DA, Hannon TS, Marcovina S, Nadeau KJ, Utzschneider KM, Xiang AH, Edelstein SL; RISE Consortium; Rise Consortium Investigators:. Hyperglucagonemia Does Not Explain the beta-Cell Hyperresponsiveness and Insulin Resistance in Dysglycemic Youth Compared With Adults: Lessons From the RISE Study. Diabetes Care. 2021 Sep;44(9):1961-1969. doi: 10.2337/dc21-0460. Epub 2021 Jun 15.
Derived from this study: PubMed 33436401Arslanian SA, El Ghormli L, Kim JY, Tjaden AH, Barengolts E, Caprio S, Hannon TS, Mather KJ, Nadeau KJ, Utzschneider KM, Kahn SE; RISE Consortium. OGTT Glucose Response Curves, Insulin Sensitivity, and beta-Cell Function in RISE: Comparison Between Youth and Adults at Randomization and in Response to Interventions to Preserve beta-Cell Function. Diabetes Care. 2021 Mar;44(3):817-825. doi: 10.2337/dc20-2134. Epub 2021 Jan 12.
Derived from this study: PubMed 32985775Hannon TS, Edelstein SL, Arslanian SA, Caprio S, Zeitler PS, Buchanan TA, Ehrmann DA, Mather KJ, Tripputi M, Kahn SE, Nadeau KJ; RISE Consortium. Withdrawal of medications leads to worsening of OGTT parameters in youth with impaired glucose tolerance or recently-diagnosed type 2 diabetes. Pediatr Diabetes. 2020 Dec;21(8):1437-1446. doi: 10.1111/pedi.13129. Epub 2020 Oct 13.
Individual participant dataSharing planned: Yes. Will share all research data via the NIDDK repository 2 years after final patient visit from the RISE consortium in ~2020. Data may be obtained from the repository directly.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Metformin and Glargine in people with Prediabetes and Type 2 Diabetes, run by RISE Study Group at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ß-cell Response Measured by Hyperglycemic Clamp (time frame: 3-months after medication washout (Month 15)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01779375, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.