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A Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 Years) With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT03170518
Recruitment Status : Recruiting
First Posted : May 31, 2017
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The purpose of this study is to assess the effect of canagliflozin relative to placebo on glycated hemoglobin (HbA1c) after 26 weeks of treatment, and to assess the overall safety and tolerability of canagliflozin after 52 weeks of treatment.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Canagliflozin 100 mg Drug: Canagliflozin 300 mg Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (≥10 to <18 Years) With Type 2 Diabetes Mellitus
Actual Study Start Date : July 21, 2017
Estimated Primary Completion Date : June 28, 2021
Estimated Study Completion Date : June 28, 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Single-blind run-in Period: Placebo
Participants will receive 1 placebo tablet matching canagliflozin 100 milligram (mg) once-daily during the 2-week single-blind placebo run-in period.
Drug: Placebo
Matching placebo tablet will be administered orally once-daily.
Experimental: Double-blind Treatment Phase: Canagliflozin or Placebo
Canagliflozin 100 mg/matching placebo once-daily during first 12 weeks. At Week 13, participants who have glycated hemoglobin (HbA1c) of greater than or equal to (>=)7.0 percent (%), estimated glomerular filtration rate (eGFR) >=60 milliliter/minute/1.73 meter square (mL/min/1.73 m^2) will be re-randomized to either remain on canagliflozin 100 mg/matching placebo or up-titrate to canagliflozin 300 mg/matching placebo till Week 52.
Drug: Canagliflozin 100 mg
Canagliflozin 100 mg tablet will be administered orally (by mouth) once-daily.
Other Name: JNJ-28431754
Drug: Canagliflozin 300 mg
Canagliflozin 300 mg tablet will be administered orally once-daily.
Other Name: JNJ-28431754
Drug: Placebo
Matching placebo tablet will be administered orally once-daily.



Primary Outcome Measures :
  1. Change in Glycated Hemoglobin (HbA1c) From Baseline at Week 26 [ Time Frame: Baseline (Day 1) and Week 26 ]
    Change from baseline in HbA1c at Week 26 will be analyzed using a mixed model for repeated measures (MMRM).


Secondary Outcome Measures :
  1. Change in Fasting Plasma Glucose (FPG) From Baseline at Week 26 and Week 52 [ Time Frame: Baseline (Day 1), Week 26, and Week 52 ]
    Change from baseline in FPG at Week 26 and Week 52 will be assessed.

  2. Percentage of Participants With HbA1c less than (<)7.5 percent (%) at Week 26 and Week 52 [ Time Frame: Week 26 and Week 52 ]
    The percentage of participants achieving HbAIc <7.5% at Week 26 and Week 52 will be assessed.

  3. Percentage of Participants With HbA1c <7.0% at Week 26 and Week 52 [ Time Frame: Week 26 and Week 52 ]
    The percentage of participants achieving HbAIc <7% at Week 26 and Week 52 will be assessed.

  4. Percentage of Participants With HbA1c <6.5% at Week 26 and Week 52 [ Time Frame: Week 26 and Week 52 ]
    The percentage of participants achieving HbAIc <6.5% at Week 26 and Week 52 will be assessed.

  5. Time to Rescue Therapy [ Time Frame: Baseline (Day 1) up to Week 26 and Week 52 ]
    Time from baseline to initiation of glycemic rescue therapy for participants not responding to treatment.

  6. Percentage of Participants who will Receive Rescue Therapy [ Time Frame: Week 26 and Week 52 ]
    Percentage of participants receiving rescue therapy will be assessed.

  7. Change in Body Weight From Baseline at Week 26 and Week 52 [ Time Frame: Baseline (Day 1), Week 26 and Week 52 ]
    The change in body weight from Baseline to Week 26 and Week 52 will be assessed.


Other Outcome Measures:
  1. Change in Body Mass Index (BMI) From Baseline at Week 26 and Week 52 [ Time Frame: Baseline (Day 1), Week 26 and Week 52 ]
    Change from baseline in BMI at Week 26 and Week 52 will be assessed.

  2. Percent Change in Fasting Plasma Lipid Levels From Baseline at Week 26 and Week 52 [ Time Frame: Baseline (Day 1), Week 26 and Week 52 ]
    The percentage change from baseline in fasting plasma lipids (low-density lipoprotein-cholesterol [LDL-C], high-density lipoprotein-cholesterol [HDL-C], total cholesterol, non-HDL-C, and triglycerides) at Week 26 and Week 52 will be assessed.

  3. Percent Change in LDL-C to HDL-C Ratio and Non-HDL-C to LDL-C Ratio From Baseline at Week 26 and Week 52 [ Time Frame: Baseline (Day 1), Week 26 and Week 52 ]
    The percentage change from baseline in ratio of LDL-C to HDL-C and non-HDL-C to LDL-C at Week 26 and Week 52 will be assessed.

  4. Change in Systolic Blood Pressure From Baseline at Week 26 and Week 52 [ Time Frame: Baseline (Day 1), Week 26 and Week 52 ]
    The change in systolic blood pressure from baseline to Week 26 and week 52 will be assessed.

  5. Change in Diastolic Blood Pressure From Baseline at Week 26 and Week 52 [ Time Frame: Baseline (Day 1), Week 26 and Week 52 ]
    The change in systolic blood pressure from baseline to Week 26 and week 52 will be assessed.

  6. Change in HbA1c From Baseline at Week 12 and Week 52 [ Time Frame: Baseline (Day 1), Week 12 and Week 52 ]
    Change from Baseline in HbA1c at Week 12 and Week 52 will be assessed.

  7. Change in Growth Velocity From Baseline at Week 26 and Week 52 [ Time Frame: Baseline (Day 1), Week 26 and Week 52 ]
    The change in growth velocity from baseline at Week 26 and Week 52 will be assessed.

  8. Change in Tanner Staging From Baseline at Week 26 and Week 52 [ Time Frame: Baseline (Day 1), Week 26 and Week 52 ]
    The change in tanner staging from baseline at Week 26 and Week 52 will be assessed. A low stage (Stage I) corresponds to a pre-pubertal stage and a high stage (Stage V) to an adult stage.

  9. Change in Bone Turnover Marker: Serum Osteocalcin From Baseline at Week 26 and Week 52 [ Time Frame: Baseline (Day 1), Week 26 and Week 52 ]
    Change from baseline in serum osteocalcin (bone turnover marker) at Week 26 and Week 52 will be assessed.

  10. Change in Bone Turnover Marker: Serum Collagen Type 1 Carboxy-Telopeptide (CTx) From Baseline at Week 26 and Week 52 [ Time Frame: Baseline (Day 1), Week 26 and Week 52 ]
    Change from baseline in serum collagen Type 1 CTx (bone turnover marker) at Week 26 and Week 52 will be assessed.

  11. Change in Urinary Albumin/Creatinine Ratio (ACR) From Baseline at Week 26 and Week 52 [ Time Frame: Baseline (Day 1), Week 26 and Week 52 ]
    Change from baseline in urinary ACR at Week 26 and Week 52 will be assessed.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants with a diagnosis of type 2 diabetes mellitus (T2DM)
  • Random C-peptide at screening greater than (>)0.6 nanogram/milliliter (ng/mL) (>0.2 nanomole/liter [nmol]/L])
  • HbA1c of greater than or equal to (>=)6.5 percent (%) to less than or equal to (<=)10.5% and either

    1. On diet and exercise alone during the 8 weeks prior to screening
    2. On diet and exercise and a stable dose of metformin monotherapy >=1,000 mg per day for at least 8 weeks prior to screening
    3. On diet and exercise and a stable insulin monotherapy regimen for at least 8 weeks prior to screening
    4. On diet and exercise and a stable combination therapy with metformin and insulin for at least 8 weeks prior to screening

Exclusion Criteria:

  • History of diabetic ketoacidosis (DKA), type 1 diabetes mellitus (T1DM), pancreas or cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy or maturity onset diabetes of the young (MODY)
  • Participants on any antihyperglycemic agents (AHAs) other than metformin, or injectable insulin within 8 weeks of the first dose of study drug (Day 1)
  • Repeated (2 or more over a 1-week period) fasting self-monitoring of blood glucose (SMBG) measurements >270 milligram/deciliter (mg/dL) (>15 millimole/liter [mmol/L]) during the pretreatment phase, despite reinforcement of diet and exercise counseling
  • Severe hypoglycemia within 6 months prior to Day 1
  • History of hereditary glucose-galactose malabsorption or primary renal glucosuria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03170518


Contacts
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

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Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Additional Information:
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03170518     History of Changes
Other Study ID Numbers: CR108298
2016-005223-88 ( EudraCT Number )
28431754DIA3018 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Canagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs