Efficacy and Safety of Basal Insulin Glargine Combination With Exenatide Bid vs Aspart30 in T2DM

NCT02467920 | Completed Phase 4 DMC

• 1 other identifier: ESR-14-10352
• Study Type: interventional
• Target: 349
• Locations: 1 country
• Sites: 1

Brief Summary

Efficacy and Safety of Basal Insulin Glargine Combination with Exenatide bid vs Switching Premix Human Insulin to Aspart30 in T2DM with Inadequate Glycaemic Control on Premixed Human Insulin and Metformin: a Randomized, Open, Parallel trial.

Conditions

Type 2 Diabetes Mellitus

Keywords

exenatide; glargine; aspart 30

Outcome Measures

Primary Outcomes (1)

• the absolute change in HbA1c from baseline to 24-week endpoint of basal insulin glargine combination with exenatide bid vs. switching to aspart30 in type 2 diabetic patients inadequately controlled on premixed human insulin and metformin.

  from baseline to 24-week endpoint

Secondary Outcomes (6)

• Change in HbA1c from baseline to 12 weeks endpoint

  from baseline to 12 weeks endpoint

• The percentage of participants who achieved HbA1c ≤ 6.5% and < 7%

  12 weeks and 24 weeks

• Fasting blood glucose

  12 weeks and 24 weeks

• Daily insulin use

  baseline, 12 weeks and 24 weeks

• Change in body weight

  from baseline to 12 and 24 weeks

Study Arms (2)

glargine + exenatide

EXPERIMENTAL

Type 2 diabetic patients with inadequate glycaemic control on premixed human insulin and metformin previously. After a 12-week run-in period , switching premix human insulin to glargine ( once-daily subcutaneous injection at bedtime) combination with exenatide (subcutaneous injection, twice-daily).

Drug: glargine + exenatide

aspart 30

ACTIVE COMPARATOR

Type 2 diabetic patients with inadequate glycaemic control on premixed human insulin and metformin previously. After a 12-week run-in period , switching premix human insulin to aspart 30 ( subcutaneous injection, twice daily).

Drug: aspart 30

Interventions

glargine + exenatide DRUG

glargine ( once-daily subcutaneous injection at bedtime) combination with exenatide (subcutaneous injection, twice-daily)

glargine + exenatide

aspart 30 DRUG

aspart 30 ( subcutaneous injection, twice daily)

aspart 30

Eligibility Criteria

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

You may qualify if:

• Provision of informed consent
• Type 2 diabetic patients receiving twice-daily premixed human insulin 30 therapy ≥ 30 U/d and metformin with maximum tolerated dosage (≤ 1500mg/d)
• HbA1c \> 8.0 % and \< 11.0 % (HbA1c \> 7.0 % and \< 10.0% at randomization)
• Men and women (non-pregnant and using a medically approved birth-control method) aged ≥ 18 and ≤ 70 years
• BMI ≥ 23 and ≤ 35 kg/m2

You may not qualify if:

• Type 1 diabetes or other specific types of diabetes
• Pregnancy, preparation for pregnancy, lactation and women of child-bearing age incapable of effective contraception methods
• Uncooperative subject because of various reasons
• Abnormal liver function, glutamic-pyruvic transaminase (ALT) and glutamic-oxaloacetic transaminase (AST) \> twice the upper limits of normal
• Impairment of renal function, serum creatinine: ≥ 133mmol/L for female，≥ 135mmol/L for male
• Serious chronic gastrointestinal diseases
• Edema
• Serious heart diseases, such as cardiac insufficiency (level III or more according to NYHA), acute coronary syndrome and old myocardial infraction
• Blood pressure: Systolic blood pressure (SBP) ≥ 180mmHg and/or diastolic blood pressure (DBP) ≥ 110mmHg
• White blood count (WBC) \< 4.0×109/L or platelet count (PLT) \< 90×109/L，or definite anemia (Hb：\< 120g/L for male, \< 110g/L for female), or other hematological diseases
• Endocrine system diseases, such as hyperthyroidism and hypercortisolism
• Experimental drug allergy or frequent hypoglycemia
• Psychiatric disorders, drug or other substance abuse
• Diabetic ketoacidosis and hyperosmolar nonketotic coma requiring insulin therapy
• Stressful situations such as surgery, serious trauma and so on

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and technology

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; Exenatide; insulin aspart, insulin aspart protamine drug combination 30:70

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; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Endocrinology

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: June 10, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 14, 2018

Record last verified: 2018-11

Locations

CN (1)