Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 13 for:    18539917 [PUBMED-IDS]

Effectiveness & Tolerability of Novel, Initial Triple Combination Therapy vs Conventional Therapy in Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02946632
Recruitment Status : Not yet recruiting
First Posted : October 27, 2016
Last Update Posted : October 27, 2016
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Sin Gon Kim, Korea University Anam Hospital

Tracking Information
First Submitted Date  ICMJE October 25, 2016
First Posted Date  ICMJE October 27, 2016
Last Update Posted Date October 27, 2016
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2016)
Proportion of patients who met HbA1c < 6.5% without hypoglycaemia, weight gain, or discontinuation due to adverse events at 104 weeks [ Time Frame: 104 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2016)
  • ∙ Proportion of patients who met HbA1c < 6.5% without hypoglycaemia, weight gain, or discontinuation due to adverse events at 52 weeks [ Time Frame: 52 weeks ]
  • Proportion of patients who met HbA1c < 7.0% without hypoglycaemia, weight gain, or discontinuation due to adverse events at 104 weeks [ Time Frame: 104 weeks ]
  • Change in body HbA1c from baseline to week 104 [ Time Frame: 104 weeks ]
  • Change in body weight from baseline to week 104 [ Time Frame: 104 weeks ]
  • Change in systolic blood pressure from baseline to week 104 [ Time Frame: 104 weeks ]
  • Changes in fat and lean mass from baseline to at 104 weeks [ Time Frame: 104 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 26, 2016)
AEs/SAEs [ Time Frame: 104 weeks ]
hypoglycemia, GI trouble, urinary tract infection, genital infection, volume depletion, panreatitis, severe cutaneous events, hypersensitivity reactions)
  • Vital signs
  • Collection of clinical chemistry/haematology parameters
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effectiveness & Tolerability of Novel, Initial Triple Combination Therapy vs Conventional Therapy in Type 2 Diabetes
Official Title  ICMJE Effectiveness and Tolerability of Novel, Initial Triple Combination Therapy With Xigduo (Dapagliflozin Plus Metformin) and Saxagliptin vs. Conventional Stepwise add-on Therapy in Drug-naïve Patients With Type 2 Diabetes
Brief Summary In this study, the investigators will assess the efficacy and tolerability of a novel, initial triple combination therapy with metformin, saxaglipitin, and dapagliflozin, compared to conventional stepwise add-on therapy in drug-naïve patients with recently onset type 2 diabetes.
Detailed Description

ADA/EASD guideline recommends sequential treatment approach starting with metformin, and adding other classes of anti-diabetic medications if target HbA1c is not achieved. However, several clinical studies clearly showed that initial dual or triple combination therapy was more favorable in terms of glycemic control.

A DPP-4 inhibitor saxagliptin increases serum level of GLP-1, and potentiates its action of increasing glucose-dependent insulin secretion and lowering glucagon secretion. A SGLT-2 inhibitor dapagliflozin lowers hyperglycemia via blocking SGLT-2 to increase glucosuria, that is, in an insulin-independent manner. Therefore, the mechanism of action of these drugs are complimentary to that of metformin, and all of these have a low risk of hypoglycemia and weight gain.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type II
Intervention  ICMJE
  • Drug: triple combination therapy
    Xigduo (metformin 1000mg + dapagliflozin 10mg) saxagliptin 5mg
    Other Names:
    • metformin 1000mg
    • dapagliflozin 10mg
    • saxagliptin 5mg
  • Drug: Stepwise add-on therapy
    metformin -> glimepirde -> sitagliptin
    Other Names:
    • Metformin
    • Glimepiride
    • Sitagliptin
Study Arms  ICMJE
  • Experimental: Triple combination therapy group
    Xigduo (metformin 1000mg + dapagliflozin 10mg), saxagliptin 5mg once daily for 104 weeks
    Intervention: Drug: triple combination therapy
  • Active Comparator: Stepwise add-on therapy group
    • Participants were started on metformin 1000mg once daily after screening & assignment
    • At each visits, FPG and HbA1c are measured. Sequential add-on therapy regimen is described
    Intervention: Drug: Stepwise add-on therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 26, 2016)
104
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Drug-naïve patients with type 2 diabetes by American Diabetes Association criteria
  • HbA1c ≥ 8%, < 10.5% at screening
  • Age ≥ 18 years, < 65 years
  • Body mass index (BMI) ≥ 23 kg/m2, < 35 kg/m2
  • Estimated GFR (eGFR) ≥ 60 ml/min/1.73m2

Exclusion Criteria:

  • Uncontrolled hyperglycemia > 270 mg/dl after an overnight fast
  • Diabetic ketoacidosis
  • Type 1 diabetes
  • Confirmed cardiovascular disease (acute coronary syndrome, stroke, or transient ischemic attack) within 3 months of screening
  • Congestive heart failure (New York Heart Association functional class IV)
  • severe hepatic dysfunction (serum levels of either AST, ALT, or alkaline phosphatase above 3 x upper limit of normal (ULN))
  • alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
  • pregnant women, women with potential of pregnancy not using adequate contraception method as evaluated by the investigator, lactating women
  • use of systemic glucocorticoid
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: SinGon Kim, MD 010-4191-0958 k50367@korea.ac.kr
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02946632
Other Study ID Numbers  ICMJE TRIPLE-AXEL-ESR
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sin Gon Kim, Korea University Anam Hospital
Study Sponsor  ICMJE Korea University Anam Hospital
Collaborators  ICMJE AstraZeneca
Investigators  ICMJE
Principal Investigator: SinGon Kim, MD 'Korea University Anam Hospital' in Seoul, Korea
PRS Account Korea University Anam Hospital
Verification Date October 2016

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