Clinical trial NCT03359837: Comparison of Two Treatment Regimens in Patients With Type 2 Diabetes After Short-term Intensive Insulin Therapy
Official title: A 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2017-12-02
Enrollment: 384
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Change in hemoglobin A1c (HbA1c)
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Patients with fasting plasma glucose (FPG) <6.1 mmol/L
timeFrame: At Week 12 and Week 24
measure: Patients with FPG <6.1 mmol/L without hypoglycemia
timeFrame: At Week 12 and Week 24
measure: Patients with FPG <7 mmol/L
timeFrame: At Week 12 and Week 24
measure: Patients with FPG <7 mmol/L without hypoglycemia
timeFrame: At Week 12 and Week 24
measure: Patients with HbA1c <7%
timeFrame: At Week 12 and Week 24
measure: Patients with HbA1c <7% without hypoglycemia
timeFrame: At Week 12 and Week 24
measure: Hypoglycemic events
timeFrame: Baseline to Week 24
measure: Change in FPG
timeFrame: Baseline to Week 24
measure: Change in body weight
timeFrame: Baseline to Week 24
measure: Insulin dose
timeFrame: At Week 24
measure: Daily BG variation at week 24
timeFrame: At Week 24
measure: European quality of life - 5 dimensions (EQ-5D)
timeFrame: Baseline to Week 24
measure: Subgroup analysis
timeFrame: At week 24
Other outcomes:
Locations:
city: China
country: China
facility: CHINA
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Liu J, Jiang X, Xu B, Wang G, Cui N, Zhang X, Liu J, Mu Y, Guo L. Efficacy and Safety of Basal Insulin-Based Treatment Versus Twice-Daily Premixed Insulin After Short-Term Intensive Insulin Therapy in Patients with Type 2 Diabetes Mellitus in China: Study Protocol for a Randomized Controlled Trial (BEYOND V). Adv Ther. 2020 Apr;37(4):1675-1687. doi: 10.1007/s12325-020-01265-6. Epub 2020 Mar 4.