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

NCT03359837 | Completed Phase 4

• 2 other identifiers: LANTUL07194U1111-1186-3400
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in hemoglobin A1c (HbA1c)

  Change in HbA1c from baseline to week 24

  Baseline to Week 24

Secondary Outcomes (13)

• Patients with fasting plasma glucose (FPG) <6.1 mmol/L

  At Week 12 and Week 24

• Patients with FPG <6.1 mmol/L without hypoglycemia

  At Week 12 and Week 24

• Patients with FPG <7 mmol/L

  At Week 12 and Week 24

• Patients with FPG <7 mmol/L without hypoglycemia

  At Week 12 and Week 24

• Patients with HbA1c <7%

  At Week 12 and Week 24

Study Arms (2)

Glargine based therapy

EXPERIMENTAL

Once daily glargine plus prandial oral anti-hyperglycemic drugs

Drug: INSULIN GLARGINE (HOE901); Drug: Insulin Glulisine; Drug: Repaglinide; Drug: Acarbose

Premixed insulin

ACTIVE COMPARATOR

Twice daily premixed insulin

Drug: Biphasic insulin aspart 30; Drug: Metformin

Interventions

INSULIN GLARGINE (HOE901) DRUG

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

Also known as: Lantus

Glargine based therapy

Insulin Glulisine DRUG

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

Also known as: Apidra

Glargine based therapy

Biphasic insulin aspart 30 DRUG

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

Also known as: Novolog Mix70/30

Premixed insulin

Repaglinide DRUG

Pharmaceutical form: tablet Route of administration: oral administration

Also known as: NovoNorm

Glargine based therapy

Acarbose DRUG

Pharmaceutical form: tablet Route of administration: oral administration

Also known as: Glucobay

Glargine based therapy

Metformin DRUG

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

Premixed insulin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

CHINA

China, China

Location

Related Publications (1)

• 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.

  PMID: 32130661 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; insulin glulisine; insulin aspart, insulin aspart protamine drug combination 30:70; repaglinide; Acarbose; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Trisaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: December 2, 2017
• Study Start: January 20, 2018
• Primary Completion: June 29, 2020
• Study Completion: June 29, 2020
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)