Comparison of Two Treatment Regimens in Patients With Type 2 Diabetes After Short-term Intensive Insulin Therapy

ID: NCT03359837
Status: Recruiting
Phase: Phase 4
Start Date: January 20, 2018
First Submitted: November 21, 2017
Last Updated: February 20, 2018
Results: N/A
Organization: Sanofi
Sponsors & Collaborators: Sanofi
Location: China
Conditions: Type 2 Diabetes Mellitus
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Study Description

Brief Summary

Primary Objective:

To test the hypothesis that basal insulin based treatment (G+) is noninferior to twice-daily premixed insulin (PM-2) in term of hemoglobin A1c (glycosylated hemoglobin, HbA1c) reduction from baseline to end of study. The test for superiority can be done if noninferiority is achieved.

Secondary Objectives:

- To assess efficacy in terms of percentage of patients achieving HbA1c <7% and HbA1c <7% without hypoglycemia.

- To assess efficacy in terms of percentage of patients achieving fasting plasma glucose (FPG) <7 mmol/L and FPG <7 mmol/L without hypoglycemia.

- To assess safety in term of occurrence of moderate/severe hypoglycemia.

- To assess daily blood glucose (BG) variation.

- To assess patient satisfaction.

Detailed Description

The duration of study is approximately 21 months. Each patient will be followed for approximately 27 weeks from screening visit to end-of-study
Condition or disease Intervention/treatment Phase

Type 2 Diabetes Mellitus

Drug: INSULIN GLARGINE (HOE901)
Other Names
Lantus
Drug: Insulin Glulisine
Other Names
Apidra
Drug: Biphasic insulin aspart 30
Other Names
Novolog Mix70/30
Drug: Repaglinide
Other Names
NovoNorm
Drug: Acarbose
Other Names
Glucobay
Drug: Metformin
Other Names
Phase 4

Tracking Information

First Submitted DateNovember 21, 2017
Last Update Posted DateFebruary 20, 2018
Actual Start DateJanuary 20, 2018
Anticipated Completion DateNovember 07, 2019
Actual Primary Completion DateNovember 07, 2019
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Change in hemoglobin A1c (HbA1c) [Time Frame: Baseline to Week 24]

    Change in HbA1c from baseline to week 24

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Patients with fasting plasma glucose (FPG) <6.1 mmol/L [Time Frame: At Week 12 and Week 24]

    Percentage of patients with FPG <6.1 mmol/L at week 12 and week 24

  • Patients with FPG <6.1 mmol/L without hypoglycemia [Time Frame: At Week 12 and Week 24]

    Percentage of patients with FPG <6.1 mmol/L without hypoglycemia at week 12 and week 24

  • Patients with FPG <7 mmol/L [Time Frame: At Week 12 and Week 24]

    Percentage of patients with FPG <7 mmol/L at week 12 and week 2

  • Patients with FPG <7 mmol/L without hypoglycemia [Time Frame: At Week 12 and Week 24]

    Percentage of patients with FPG <7 mmol/L without hypoglycemia at week 12 and week 24

  • Patients with HbA1c <7% [Time Frame: At Week 12 and Week 24]

    Percentage of patients with HbA1c <7% at week 12 and week 24

  • Patients with HbA1c <7% without hypoglycemia [Time Frame: At Week 12 and Week 24]

    Percentage of patients with HbA1c <7% without hypoglycemia at week 12 and week 24

  • Hypoglycemic events [Time Frame: Baseline to Week 24]

    Incidence of hypoglycemia during treatment period

  • Change in FPG [Time Frame: Baseline to Week 24]

    Change in FPG from baseline to week 24

  • Change in body weight [Time Frame: Baseline to Week 24]

    Change in body weight from baseline to week 24

  • Insulin dose [Time Frame: At Week 24]

    Total daily insulin dose at week 24

  • Daily BG variation at week 24 [Time Frame: At Week 24]

    Daily blood glucose (BG) variation at week 24

  • European quality of life - 5 dimensions (EQ-5D) [Time Frame: Baseline to Week 24]

    Change in quality of life scores from baseline to week 24 on 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is measured at 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problem.

  • Subgroup analysis [Time Frame: At week 24]

    Subgroup analysis of control rate of HbA1c <7% according to duration of diabetes, oral anti-hyperglycemic drug(OAD) treatment and HbA1c at screening, FPG, post prandial glucose(PPG) excursion and C peptide at the beginning of run-in period, insulin dose at end of run-in period

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleComparison of Two Treatment Regimens in Patients With Type 2 Diabetes After Short-term Intensive Insulin Therapy
Official TitleA 26-Week, Multi-Center, Open-label, Randomized, Parallel-group Study to Evaluate the Efficacy and Safety of Two Treatment Regimens in Patients With Type 2 Diabetes After Short-Term Intensive Insulin Therapy: Basal Insulin Based Treatment (With Prandial OADs Combination) Versus Twice-daily Premixed Insulin
Brief Summary

Primary Objective:

To test the hypothesis that basal insulin based treatment (G+) is noninferior to twice-daily premixed insulin (PM-2) in term of hemoglobin A1c (glycosylated hemoglobin, HbA1c) reduction from baseline to end of study. The test for superiority can be done if noninferiority is achieved.

Secondary Objectives:

- To assess efficacy in terms of percentage of patients achieving HbA1c <7% and HbA1c <7% without hypoglycemia.

- To assess efficacy in terms of percentage of patients achieving fasting plasma glucose (FPG) <7 mmol/L and FPG <7 mmol/L without hypoglycemia.

- To assess safety in term of occurrence of moderate/severe hypoglycemia.

- To assess daily blood glucose (BG) variation.

- To assess patient satisfaction.

Detailed Description

The duration of study is approximately 21 months. Each patient will be followed for approximately 27 weeks from screening visit to end-of-study

Study TypeInterventional
Study PhasePhase 4
Estimated Enrollment
400
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
None (Open Label)
Primary Purpose
Treatment
Conditions
Type 2 Diabetes Mellitus
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: INSULIN GLARGINE (HOE901)

Pharmaceutical form: solution for injection Route of administration: subcutaneous injection

Other Names
Lantus
Drug: Insulin Glulisine

Pharmaceutical form: solution for injection Route of administration: subcutaneous injection

Other Names
Apidra
Drug: Biphasic insulin aspart 30

Pharmaceutical form: solution for injection Route of administration: subcutaneous injection

Other Names
Novolog Mix70/30
Drug: Repaglinide

Pharmaceutical form: tablet Route of administration: oral administration

Other Names
NovoNorm
Drug: Acarbose

Pharmaceutical form: tablet Route of administration: oral administration

Other Names
Glucobay
Drug: Metformin

Pharmaceutical form: tablet or capsule Route of administration: oral administration

Other Names
Study Groups/Cohorts
Glargine based therapy
Once daily glargine plus prandial oral anti-hyperglycemic drugs

Premixed insulin
Twice daily premixed insulin

Study Arms
Experimental Glargine based therapy
Once daily glargine plus prandial oral anti-hyperglycemic drugs
Drug : INSULIN GLARGINE (HOE901)
Pharmaceutical form: solution for injection Route of administration: subcutaneous injection

Experimental Glargine based therapy
Once daily glargine plus prandial oral anti-hyperglycemic drugs
Drug : Insulin Glulisine
Pharmaceutical form: solution for injection Route of administration: subcutaneous injection

Experimental Glargine based therapy
Once daily glargine plus prandial oral anti-hyperglycemic drugs
Drug : Repaglinide
Pharmaceutical form: tablet Route of administration: oral administration

Experimental Glargine based therapy
Once daily glargine plus prandial oral anti-hyperglycemic drugs
Drug : Acarbose
Pharmaceutical form: tablet Route of administration: oral administration

Active Comparator Premixed insulin
Twice daily premixed insulin
Drug : Metformin
Pharmaceutical form: tablet or capsule Route of administration: oral administration

Active Comparator Premixed insulin
Twice daily premixed insulin
Drug : Biphasic insulin aspart 30
Pharmaceutical form: solution for injection Route of administration: subcutaneous injection

Arm Intervention/Treatment
Experimental Glargine based therapy
Once daily glargine plus prandial oral anti-hyperglycemic drugs
Drug : INSULIN GLARGINE (HOE901)
Experimental Glargine based therapy
Once daily glargine plus prandial oral anti-hyperglycemic drugs
Drug : Insulin Glulisine
Experimental Glargine based therapy
Once daily glargine plus prandial oral anti-hyperglycemic drugs
Drug : Repaglinide
Experimental Glargine based therapy
Once daily glargine plus prandial oral anti-hyperglycemic drugs
Drug : Acarbose
Active Comparator Premixed insulin
Twice daily premixed insulin
Drug : Metformin
Active Comparator Premixed insulin
Twice daily premixed insulin
Drug : Biphasic insulin aspart 30

Recruitment Information

Recruitment Status:Recruiting
Enrollment400
Completion DateNovember 07, 2019
Eligibility Criteria: Inclusion criteria :
- Patients with age between 18 and 70 years.
- Hemoglobin A1c>7.5%, and ≤11%.
- Fasting plasma glucose >7 mmol/L.
- Fasting C peptide >1 ng/mL.
- Type 2 diabetes (T2DM) patients with diabetes diagnosis between 2 and 10 years (World Health Organization 1999 T2DM diagnose criteria).
- Continuous treatment with stable doses of metformin (≥1 g/day) and 1 oral antihyperglycemic drug (at least half maximum dose) for more than 3 months prior to screening.
- Body mass index ≥21 kg/m2, and <40 kg/m2.
Exclusion criteria:
- More than 7 consecutive days of insulin treatment within the 12 months except for acute disease or surgery.
- Diabetes other than T2DM (e.g. type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake).
- History of hypoglycemia unawareness or recurrent hypoglycemia or severe hypoglycemia within the past 12 months.
- History of sensitivity to the study drugs or to drugs with a similar chemical structure.
- Pregnancy or planned pregnancy or current lactation (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method).
- Acute diabetic complications (diabetic ketoacidosis, lactic acidosis, hyperosmolar nonketotic diabetic coma) within the past 12 months.
- Significant diabetic complications and serious disease, e.g., symptomatic autonomic neuropathy, gastroparesis, unstable angina or active proliferative retinopathy.
- Acute infections which may affect BG control within the past 4 weeks.
- Active liver disease, alanine transaminase (ALT) and/or aspartate aminotransferase (AST) greater than two times the upper limit of the reference range at screening.
- Impaired renal function, defined as but not limited to, serum creatinine levels ≥1.5 mg/dL (132 μmol/L) for males and ≥1.4 mg/dL (123 μmol/L) for females or presence of macroproteinuria (>2 g/day).
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
GenderAll
Age18 Years to 70 Years
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
China

Administrative Information

NCT Number:NCT03359837
Other Study ID Numbers
LANTUL07194
U1111-1186-3400
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Sanofi
Collaborators
Not Available
Investigators
Study Director
Clinical Sciences & Operations
Sanofi