Phase 3
Completed N=91
RISE Pediatric Medication Study
Source: ClinicalTrials.gov NCT01779375 ↗Enrolled (actual)
91
Serious AEs
7.7%
Results posted
Oct 2018
Primary outcomePrimary: ß-cell Response Measured by Hyperglycemic Clamp — 4.82; 4.18; 6.92; 5.95 nmol/L — p=>0.05
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ß-cell Response Measured by Hyperglycemic Clamp |
4.82; 4.18; 6.92; 5.95 | >0.05 |
| PRIMARY M/I |
1.48; 1.70 | >0.05 |
| SECONDARY ACPRg |
1.11; 1.12 | — |
| SECONDARY ß-cell Function Measured by Hyperglycemic Clamp Techniques at M12 |
4.78; 4.37; 6.95; 5.79; 1.06; 1.03 | >0.05 |
| SECONDARY Clamp Measure of Insulin Sensitivity |
1.52; 1.93 | — |
Eligibility Criteria
Inclusion Criteria
- 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 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 1 week preceding screening
- Active infections
- Renal disease (serum creatinine >1.2 mg/dl) or serum potassium abnormality ( 5.5 mmol/l)
- Anemia (hemoglobin 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.
Data sourced from ClinicalTrials.gov (NCT01779375). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.