search
Back to results

Evaluation of the Safety and Efficacy of Insulin Glargine + Glulisine or Insulin Regular + NPH Insulin (Isophane Insulin) Use in Type 2 Diabetes Mellitus Patients With Moderate Renal Failure. (DINAMO)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
INSULIN GLARGINE
NPH insulin (insulin isophane)
INSULIN GLULISINE
Regular insulin
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Type 2 diabetes and renal failure in use of NPH regular insulin or fast-acting analog and HbA1c >= 8%.
  • Albuminuria or microalbuminuria diabetic retinopathy.
  • Creatinine clearance < 60 mL/min/1,73 m2 and >30 mL/min/1,73 m2

Exclusion criteria:

  • Hypersensibility to insulin glargine or any other component of the insulin formulation.
  • Use of investigational medications during the last 12 months or use of any investigational insulin preparation during the last 4 months.
  • History of diabetic ketoacidosis or positive GAD antibodies.
  • Advanced retinopathy needing laser therapy.
  • Diagnosed advanced neuropathy
  • Severe hepatic disease or active hepatitis.
  • Cardiac failure class III or IV (NYHA).
  • Patients on hemodialysis.
  • Diagnosed cancer.
  • Active infection.
  • Current therapy with steroids.
  • Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

  • Investigational Site Number 076-007
  • Investigational Site Number 076-010
  • Investigational Site Number 076-001
  • Investigational Site Number 076-003
  • Investigational Site Number 076-005
  • Investigational Site Number 076-013
  • Investigational Site Number 076-004
  • Investigational Site Number 076-002
  • Investigational Site Number 076-009
  • Investigational Site Number 076-006

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

group 1: insulin glargine + insulin glulisine

group 2 NPH insulin + regular insulin

Arm Description

insulin glargine once daily + glulisine at meal times

NPH insulin (isophane insulin) (2 or more divided doses) + regular insulin at meal times

Outcomes

Primary Outcome Measures

Proportion of patients that reach the target of HbA1c ≤7% without confirmed nocturnal hypoglycaemia in each treatment group and the respective CI 90%.

Secondary Outcome Measures

Proportion of patients that reach the target of HbA1c ≤7% and proportion of patients reaching the target of Fasting Plasma Glucose (FPG ≤100mg/dL).
Incidence of confirmed symptomatic and nocturnal hypoglycemias: plasma glucose measurement <= 70mg/dL.
Incidence of confirmed severe hypoglycemia: plasma glucose level < 36 mg/dL (2 mmol/L) or with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration
Weight variation
Creatinine clearance variation

Full Information

First Posted
May 11, 2010
Last Updated
November 7, 2013
Sponsor
Sanofi
search

1. Study Identification

Unique Protocol Identification Number
NCT01122979
Brief Title
Evaluation of the Safety and Efficacy of Insulin Glargine + Glulisine or Insulin Regular + NPH Insulin (Isophane Insulin) Use in Type 2 Diabetes Mellitus Patients With Moderate Renal Failure.
Acronym
DINAMO
Official Title
National (Brazil), Phase IV, Multicentric, Open Label, Parallel, Comparative Study of the Use of Insulin Glargine + Glulisine or Insulin Regular + NPH Insulin (Isophane Insulin) in Type 2 Diabetes Mellitus Patients With Moderate Renal Failure.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Primary Objective: >To obtain an estimation for both treatment groups of the proportion of patients that reach the target of HbA1c <= 7% without confirmed nocturnal hypoglycaemia in each treatment group. Secondary Objectives: Glycemic control, measured by HbA1c and FPG (fasting plasma glucose) at baseline and after each period of treatment. Incidence of confirmed symptomatic and nocturnal hypoglycemia. Incidence of confirmed severe hypoglycemia (< 36mg/dL or need of help to recover). >Weight variation for each period of treatment. Creatinine clearance at baseline and after each period of treatment. Overall safety: Incidence of adverse events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group 1: insulin glargine + insulin glulisine
Arm Type
Experimental
Arm Description
insulin glargine once daily + glulisine at meal times
Arm Title
group 2 NPH insulin + regular insulin
Arm Type
Active Comparator
Arm Description
NPH insulin (isophane insulin) (2 or more divided doses) + regular insulin at meal times
Intervention Type
Drug
Intervention Name(s)
INSULIN GLARGINE
Intervention Description
Pharmaceutical form: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 mL) Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia
Intervention Type
Drug
Intervention Name(s)
NPH insulin (insulin isophane)
Intervention Description
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia
Intervention Type
Drug
Intervention Name(s)
INSULIN GLULISINE
Intervention Description
Pharmaceutical form: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 mL) Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia
Intervention Type
Drug
Intervention Name(s)
Regular insulin
Intervention Description
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia
Primary Outcome Measure Information:
Title
Proportion of patients that reach the target of HbA1c ≤7% without confirmed nocturnal hypoglycaemia in each treatment group and the respective CI 90%.
Time Frame
From visit 1 (Day 1) to visit 13 (Day 169)
Secondary Outcome Measure Information:
Title
Proportion of patients that reach the target of HbA1c ≤7% and proportion of patients reaching the target of Fasting Plasma Glucose (FPG ≤100mg/dL).
Time Frame
From baseline and Visit 13 (Day 169)
Title
Incidence of confirmed symptomatic and nocturnal hypoglycemias: plasma glucose measurement <= 70mg/dL.
Time Frame
From baseline and Visit 13 (Day 169)
Title
Incidence of confirmed severe hypoglycemia: plasma glucose level < 36 mg/dL (2 mmol/L) or with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration
Time Frame
From baseline and Visit 13 (Day 169)
Title
Weight variation
Time Frame
From baseline to the end of treatment at visit 13 (day 169)
Title
Creatinine clearance variation
Time Frame
From baseline to the end of treatment at visit 13 (day 169)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Type 2 diabetes and renal failure in use of NPH regular insulin or fast-acting analog and HbA1c >= 8%. Albuminuria or microalbuminuria diabetic retinopathy. Creatinine clearance < 60 mL/min/1,73 m2 and >30 mL/min/1,73 m2 Exclusion criteria: Hypersensibility to insulin glargine or any other component of the insulin formulation. Use of investigational medications during the last 12 months or use of any investigational insulin preparation during the last 4 months. History of diabetic ketoacidosis or positive GAD antibodies. Advanced retinopathy needing laser therapy. Diagnosed advanced neuropathy Severe hepatic disease or active hepatitis. Cardiac failure class III or IV (NYHA). Patients on hemodialysis. Diagnosed cancer. Active infection. Current therapy with steroids. Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 076-007
City
Curitiba
ZIP/Postal Code
80060-900
Country
Brazil
Facility Name
Investigational Site Number 076-010
City
Fortaleza
ZIP/Postal Code
60015-052
Country
Brazil
Facility Name
Investigational Site Number 076-001
City
Fortaleza
ZIP/Postal Code
60115-282
Country
Brazil
Facility Name
Investigational Site Number 076-003
City
Porto Alegre
ZIP/Postal Code
91350-250
Country
Brazil
Facility Name
Investigational Site Number 076-005
City
São Paulo
ZIP/Postal Code
01244-030
Country
Brazil
Facility Name
Investigational Site Number 076-013
City
São Paulo
ZIP/Postal Code
01308-050
Country
Brazil
Facility Name
Investigational Site Number 076-004
City
São Paulo
ZIP/Postal Code
01323-001
Country
Brazil
Facility Name
Investigational Site Number 076-002
City
São Paulo
ZIP/Postal Code
04024-002
Country
Brazil
Facility Name
Investigational Site Number 076-009
City
São Paulo
ZIP/Postal Code
o4039-000
Country
Brazil
Facility Name
Investigational Site Number 076-006
City
Taguatinga
ZIP/Postal Code
72155000
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Safety and Efficacy of Insulin Glargine + Glulisine or Insulin Regular + NPH Insulin (Isophane Insulin) Use in Type 2 Diabetes Mellitus Patients With Moderate Renal Failure.

We'll reach out to this number within 24 hrs