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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

384 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-20

Study Completion Date

2020-06-29

Brief Summary

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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.

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Detailed Description

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

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Glargine based therapy

Once daily glargine plus prandial oral anti-hyperglycemic drugs

Group Type EXPERIMENTAL

INSULIN GLARGINE (HOE901)

Intervention Type DRUG

Pharmaceutical form: solution for injection

Route of administration: subcutaneous injection

Insulin Glulisine

Intervention Type DRUG

Pharmaceutical form: solution for injection

Route of administration: subcutaneous injection

Repaglinide

Intervention Type DRUG

Pharmaceutical form: tablet

Route of administration: oral administration

Acarbose

Intervention Type DRUG

Pharmaceutical form: tablet

Route of administration: oral administration

Premixed insulin

Twice daily premixed insulin

Group Type ACTIVE_COMPARATOR

Biphasic insulin aspart 30

Intervention Type DRUG

Pharmaceutical form: solution for injection

Route of administration: subcutaneous injection

Metformin

Intervention Type DRUG

Pharmaceutical form: tablet or capsule

Route of administration: oral administration

Interventions

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INSULIN GLARGINE (HOE901)

Pharmaceutical form: solution for injection

Route of administration: subcutaneous injection

Intervention Type DRUG

Insulin Glulisine

Pharmaceutical form: solution for injection

Route of administration: subcutaneous injection

Intervention Type DRUG

Biphasic insulin aspart 30

Pharmaceutical form: solution for injection

Route of administration: subcutaneous injection

Intervention Type DRUG

Repaglinide

Pharmaceutical form: tablet

Route of administration: oral administration

Intervention Type DRUG

Acarbose

Pharmaceutical form: tablet

Route of administration: oral administration

Intervention Type DRUG

Metformin

Pharmaceutical form: tablet or capsule

Route of administration: oral administration

Intervention Type DRUG

Other Intervention Names

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Lantus Apidra Novolog Mix70/30 NovoNorm Glucobay

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No