Safety, Tolerability and Efficacy of ISIS-GCGRRx in Type 2 Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Isis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01885260
First received: June 13, 2013
Last updated: November 12, 2013
Last verified: November 2013

June 13, 2013
November 12, 2013
July 2013
December 2014   (final data collection date for primary outcome measure)
The effect of ISIS-GCGRRx on serum fructosamine [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
Change from Baseline to Week 14
Same as current
Complete list of historical versions of study NCT01885260 on ClinicalTrials.gov Archive Site
  • The safety of ISIS-GCGRRx [ Time Frame: 25 Weeks ] [ Designated as safety issue: Yes ]
    By determining the incidence, severity, dose-relationship adverse effects, and changes in laboratory evaluations
  • The tolerability of ISIS-GCGRRx [ Time Frame: 25 Weeks ] [ Designated as safety issue: No ]
    By determining the incidence, severity, dose-relationship adverse effects, and changes in laboratory evaluations
  • To evaluate the safety of ISIS-GCGRRx [ Time Frame: 25 Weeks ] [ Designated as safety issue: Yes ]
    By determining the incidence, severity, dose-relationship adverse effects, and changes in laboratory evaluations
  • To evaluate the tolerability of ISIS-GCGRRx [ Time Frame: 25 Weeks ] [ Designated as safety issue: No ]
    By determining the incidence, severity, dose-relationship adverse effects, and changes in laboratory evaluations
Not Provided
Not Provided
 
Safety, Tolerability and Efficacy of ISIS-GCGRRx in Type 2 Diabetes
A Double Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of ISIS 449884 Administered Once Weekly to Patients With Type 2 Diabetes Mellitus Being Treated With Metformin

The purpose of this study is to evaluate the efficacy, safety and tolerability of ISIS-GCGRRx in combination with metformin versus placebo + metformin

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: ISIS-GCGRRx - Dose Level 1
    3 doses on alternate days during the first week and then once weekly for 12 weeks + daily metformin
  • Drug: ISIS-GCGRRx - Dose Level 2
    3 doses on alternate days during the first week and then once weekly for 12 weeks + daily metformin
  • Drug: Placebo
    3 doses on alternate days during the first week and then once weekly for 12 weeks + daily metformin
  • Experimental: ISIS-GCGRRx Group 1
    Intervention: Drug: ISIS-GCGRRx - Dose Level 1
  • Experimental: ISIS-GCGRRx Group 2
    Intervention: Drug: ISIS-GCGRRx - Dose Level 2
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
72
February 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female, age 18 to 75
  • BMI greater than or equal to 25
  • HbA1c greater than or equal to 7.5% and less than or equal to 10.5%
  • Type 2 Diabetes Mellitus and on stable dose of oral metformin
  • Agree to conduct home-based (fasted) blood glucose testing as directed

Exclusion Criteria:

  • Clinically significant abnormalities in medical history or physical exam
  • Show evidence of uncorrected hypothyroidism or hyperthyroidism hormone results
  • History of renal transplantation or renal dialysis
  • History of liver disease
  • History of greater than 3 episodes of severe hypoglycemia within 6 months of screening
  • Use of oral anti-diabetic medication other than metformin within 3 months of screening
  • History of diabetic ketoacidosis
  • Any other significant illness or condition that may interfere with the patient participating or completing the study
  • Inability or unwillingness to comply with protocol or study procedures
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   South Africa
 
NCT01885260
ISIS 449884-CS2
No
Isis Pharmaceuticals
Isis Pharmaceuticals
Not Provided
Not Provided
Isis Pharmaceuticals
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP