NCT01630369

Brief Summary

Primary Objective: \- To evaluate the decrease of Hb A1c ≥ 1% after 6 month treatment in patients with Type 2 Diabetes Mellitus (T2DM) uncontrolled on Oral Antidiabetics (OADs) Secondary Objectives:

  • To evaluate the percentage of patients with Hb A1c \< 7.5%,
  • To evaluate the rate of hypoglycaemia (symptomatic, severe)
  • To evaluate the middle dose of insulin per product - Insuman Basal, Insuman Comb, Insuman Rapid after 6 month treatment
  • To evaluate the change in Fasting Plasma Glucose (FPG) after 6 month treatment
  • To assess the overall safety
  • To evaluate the efficacy of education courses in Diabetes Schools (% of correct answers after second test compare to the testing of the initial level)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
552

participants targeted

Target at P75+ for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

May 19, 2014

Status Verified

May 1, 2014

Enrollment Period

1.2 years

First QC Date

June 26, 2012

Last Update Submit

May 16, 2014

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Decrease of Hb A1c ≥ 1%

    Baseline, 6 months

Secondary Outcomes (6)

  • Percentage of patients with Hb A1c < 7.5%

    6 months

  • Rate of hypoglycaemias (symptomatic, severe)

    6 months

  • Middle dose of insulin per product (Insuman Basal, Insuman Comb, Insuman Rapid)

    6 months

  • Change in FPG

    Baseline 6 months

  • Number of patients with adverse events

    6 months

  • +1 more secondary outcomes

Study Arms (1)

Human Insulin

EXPERIMENTAL

Dosage of human insulin (Insuman Basal/Comb/Rapid) will be individually adjusted in accordance with the Summary of Product Characteristics (SmPC). Patients will follow the titration algorithm recommended by the physician.

Drug: insulin human (HR1799)

Interventions

insulin human (HR1799)DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Also known as: Insuman Basal / Insuman Comb / Insuman Rapid
Human Insulin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • T2DM patients uncontrolled by maximum tolerated dose of 1-2 OADs
  • Males and Female \> 18 years
  • HbA1c \> 7.5%
  • Patients with abilities of self-monitoring of Diabetes, managing of patient's diary, ability to obtain education in Diabetes School, completion of Questionnaire
  • It is expected that the patient will remain on a stable dose of OADs within 6 months of treatment

You may not qualify if:

  • Type 1 diabetes
  • Current temporary insulin therapy (gestational diabetes, pancreas cancer, surgery, clinical trial)
  • Any clinically significant acute major organ or systemic diseases making interpretation of the evaluation results difficult
  • Patient planning a pregnancy now or in the next 6 months
  • The patient is participating in another clinical study now or in the last 28 days prior to Visit 1
  • The patient is a drug user (currently or in the past)
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis Administrative Office

Kyiv, Ukraine

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

June 26, 2012

First Posted

June 28, 2012

Study Start

February 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

May 19, 2014

Record last verified: 2014-05

Locations

UA(1)