Treatment of Type 2 Diabetes With Long Acting Basal Insulin in Jordan

NCT02606357 | Completed Phase 4

• 2 other identifiers: LANTUL07225U1111-1172-1002
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective:

• To assess the change in glycosylated hemoglobin (HbA1c) in uncontrolled Type 2 diabetes patients on OAD agent in Jordan after 6 months of treatment with basal insulin (Insulin glargine). Secondary Objectives:
• To evaluate the percentage of patients achieving target of HbA1c ˂7%.
• To evaluate the change in fasting plasma glucose (FPG).
• To assess the following safety criteria: hypoglycemic events, body weight changes, and overall safety.
• Describe the titration process: changes in glargine insulin dose at 3 months and 6 months, changes in the titration doses used (if any), and time to reach control.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change from baseline in HbA1c

  Baseline, 6 months

Secondary Outcomes (8)

• - Percentage of patients achieving target of HbA1c <7%

  6 months

• - Change from baseline in fasting plasma glucose values

  Baseline, 3 months, and 6 months

• - Percentage of patients with hypoglycemic events

  Baseline, 6 months

• - Change from baseline in body weight

  Baseline, 3 months and 6 months

• - Number of patients with adverse events

  Baseline, 6 months

Study Arms (1)

HOE901

EXPERIMENTAL

HOE901 administered subcutaneously once a day in the evening, at dinner, or at bedtime with titration based on FPG levels

Drug: INSULIN GLARGINE

Interventions

INSULIN GLARGINE DRUG

Pharmaceutical form:Solution Route of administration: Subcutaneous

Also known as: HOE901

HOE901

Eligibility Criteria

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

You may qualify if:

• Patient ≥ 18 years old.
• Male or Female.
• Type 2 diabetes patients.
• Uncontrolled with previous therapy (HbA1c \>7%), evident in HbA1c test within the last 1 month before study entry.
• Insulin naïve patients: any patient uncontrolled after one or a maximum of two lines of therapy including: monotherapy (Metformin alone or any other Oral Anti-Diabetic agent (OAD) if contraindicated or intolerance) and/or dual therapy (any OAD combination), at maximum tolerated dose in the last 3 months.
• Signed informed consent.
• Signed informed consent.

You may not qualify if:

• Patient not willing or not able to perform self-monitoring blood glucose.
• Patient not willing or not able to self-titrate insulin glargine under physician's guidance.
• Patient not suitable for participation according to what is specified in the approved Summary of Product's Characteristics or according to medical or clinical conditions, as judged by the Investigator.
• History of impaired hepatic function defined as alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than three times the upper limit of normal, evident in testing done in the last 3 months.
• History of impaired renal function defined as serum creatinine \>135 μmol/L (\>1.525 mg/dL)in men and \>110 μmol/L (\>1.243 mg/dL) in women, evident in testing done in the last 3 months.
• Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method at physician's discretion).
• Treatment with systemic corticosteroid within 3 months prior to study entry.
• 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)

JORDAN

Jordan, Jordan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

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

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 13, 2015
• First Posted: November 17, 2015
• Study Start: November 22, 2015
• Primary Completion: November 27, 2017
• Study Completion: November 27, 2017
• Last Updated: October 12, 2018

Record last verified: 2018-10

Locations

JO (1)