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Trial record 93 of 2355 for:    "Diabetes Mellitus, Insulin-Dependent"

A Study of Effects of Canagliflozin as Add-on Therapy to Insulin in the Treatment of Participants With Type 1 Diabetes Mellitus (T1DM)

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ClinicalTrials.gov Identifier: NCT02139943
Recruitment Status : Completed
First Posted : May 16, 2014
Results First Posted : July 18, 2016
Last Update Posted : July 18, 2016
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 1
Interventions Drug: Canagliflozin 100 mg
Drug: Canagliflozin 300 mg
Drug: Placebo
Enrollment 352
Recruitment Details  
Pre-assignment Details A total of 614 participants were screened and 352 subjects (57.3%) were randomized to study drug. One subject randomized to placebo did not take any study drug and withdrew consent on the day of randomization.
Arm/Group Title Placebo Canagliflozin 100 Milligram (mg) Canagliflozin 300 mg
Hide Arm/Group Description Participants received canagliflozin matching placebo capsules once daily for 18 weeks. Participants received 100 mg of canagliflozin capsules once daily for 18 weeks. Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
Period Title: Overall Study
Started 117 117 117
Completed 107 111 110
Not Completed 10 6 7
Reason Not Completed
Adverse Event             0             1             2
Lost to Follow-up             3             2             2
Withdrawal by Subject             4             3             0
Other             0             0             1
Participant wishes to discontinue             2             0             0
Participant in Poor Compliance             1             0             1
eGFR Withdrawal Criteria             0             0             1
Arm/Group Title Placebo Canagliflozin 100 Milligram (mg) Canagliflozin 300 mg Total
Hide Arm/Group Description Participants received canagliflozin matching placebo capsules once daily for 18 weeks. Participants received 100 mg of canagliflozin capsules once daily for 18 weeks. Participants received 300 mg of canagliflozin capsules once daily for 18 weeks. Total of all reporting groups
Overall Number of Baseline Participants 117 117 117 351
Hide Baseline Analysis Population Description
Modified intent-to-treat analysis set included all randomized participants who took at least 1 dose of double-blind study drug.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 117 participants 117 participants 117 participants 351 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
117
 100.0%
115
  98.3%
115
  98.3%
347
  98.9%
>=65 years
0
   0.0%
2
   1.7%
2
   1.7%
4
   1.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 117 participants 117 participants 117 participants 351 participants
42  (11.9) 42  (11.6) 42.8  (10.96) 42.3  (11.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 117 participants 117 participants 117 participants 351 participants
Female
54
  46.2%
48
  41.0%
52
  44.4%
154
  43.9%
Male
63
  53.8%
69
  59.0%
65
  55.6%
197
  56.1%
Region Enroll  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 117 participants 117 participants 117 participants 351 participants
Canada 24 19 20 63
United Stats 93 98 97 288
1.Primary Outcome
Title Percentage of Participants With Hemoglobin A1c (HbA1c) Reduction Greater Than or Equal to (>=) 0.4 Percent (%) and no Increase in Body Weight
Hide Description Clinical response at Weeks 18 was assessed by the percentage of participants with Hemoglobin A1c (HbA1c) reduction greater than or equal to 0.4 % and had no increase in body weight.
Time Frame Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat analysis set included all randomized participants who took at least 1 dose of double-blind study drug. 'N (Number of Participants Analyzed)’ signifies participants who were evaluable for this outcome measure.
Arm/Group Title Placebo Canagliflozin 100 Milligram (mg) Canagliflozin 300 mg
Hide Arm/Group Description:
Participants received canagliflozin matching placebo capsules once daily for 18 weeks.
Participants received 100 mg of canagliflozin capsules once daily for 18 weeks.
Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
Overall Number of Participants Analyzed 110 111 111
Measure Type: Number
Unit of Measure: percentage of participants
Yes 14.5 36.9 41.4
No 85.5 63.1 58.6
2.Primary Outcome
Title Percentage of Participants With Adverse Events
Hide Description [Not Specified]
Time Frame Up to 22 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all randomized participants who took at least 1 dose of double-blind study drug.
Arm/Group Title Placebo Canagliflozin 100 Milligram (mg) Canagliflozin 300 mg
Hide Arm/Group Description:
Participants received canagliflozin matching placebo capsules once daily for 18 weeks.
Participants received 100 mg of canagliflozin capsules once daily for 18 weeks.
Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
Overall Number of Participants Analyzed 117 117 117
Measure Type: Number
Unit of Measure: percentage of participants
54.7 55.6 67.5
Time Frame Up to 22 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Canagliflozin 100 Milligram (mg) Canagliflozin 300 mg
Hide Arm/Group Description Participants received canagliflozin matching placebo capsules once daily for 18 weeks. Participants received 100 mg of canagliflozin capsules once daily for 18 weeks. Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
All-Cause Mortality
Placebo Canagliflozin 100 Milligram (mg) Canagliflozin 300 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Canagliflozin 100 Milligram (mg) Canagliflozin 300 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/117 (0.00%)   9/117 (7.69%)   8/117 (6.84%) 
General disorders       
Non-cardiac chest pain * 1  0/117 (0.00%)  1/117 (0.85%)  0/117 (0.00%) 
Infections and infestations       
Cellulitis * 1  0/117 (0.00%)  1/117 (0.85%)  0/117 (0.00%) 
Metabolism and nutrition disorders       
Dehydration * 1  0/117 (0.00%)  1/117 (0.85%)  0/117 (0.00%) 
Diabetic ketoacidosis * 1  0/117 (0.00%)  5/117 (4.27%)  7/117 (5.98%) 
Hypoglycaemia * 1  0/117 (0.00%)  0/117 (0.00%)  1/117 (0.85%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Papillary thyroid cancer * 1  0/117 (0.00%)  1/117 (0.85%)  0/117 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Canagliflozin 100 Milligram (mg) Canagliflozin 300 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   32/117 (27.35%)   36/117 (30.77%)   43/117 (36.75%) 
Gastrointestinal disorders       
Nausea * 1  3/117 (2.56%)  4/117 (3.42%)  6/117 (5.13%) 
Infections and infestations       
Nasopharyngitis * 1  10/117 (8.55%)  9/117 (7.69%)  6/117 (5.13%) 
Sinusitis * 1  6/117 (5.13%)  2/117 (1.71%)  3/117 (2.56%) 
Upper respiratory tract infection * 1  11/117 (9.40%)  10/117 (8.55%)  10/117 (8.55%) 
Urinary tract infection * 1  2/117 (1.71%)  5/117 (4.27%)  6/117 (5.13%) 
Vulvovaginal mycotic infection * 1  1/117 (0.85%)  2/117 (1.71%)  8/117 (6.84%) 
Metabolism and nutrition disorders       
Hypoglycaemia * 1  3/117 (2.56%)  1/117 (0.85%)  7/117 (5.98%) 
Renal and urinary disorders       
Pollakiuria * 1  3/117 (2.56%)  5/117 (4.27%)  8/117 (6.84%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, 17.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Results Point of Contact
Name/Title: Senior Director Clinical Research
Organization: Janssen Research & Development, LLC
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02139943     History of Changes
Other Study ID Numbers: CR104173
2013-005078-24 ( EudraCT Number )
28431754DIA2004 ( Other Identifier: Janssen Research & Development, LLC )
First Submitted: May 14, 2014
First Posted: May 16, 2014
Results First Submitted: June 7, 2016
Results First Posted: July 18, 2016
Last Update Posted: July 18, 2016