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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01122979
First received: May 11, 2010
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: INSULIN GLARGINE
Drug: NPH insulin (insulin isophane)
Drug: INSULIN GLULISINE
Drug: Regular insulin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Sanofi:

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%. [ Time Frame: From visit 1 (Day 1) to visit 13 (Day 169) ] [ Designated as safety issue: No ]

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). [ Time Frame: From baseline and Visit 13 (Day 169) ] [ Designated as safety issue: No ]
  • Incidence of confirmed symptomatic and nocturnal hypoglycemias: plasma glucose measurement <= 70mg/dL. [ Time Frame: From baseline and Visit 13 (Day 169) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Weight variation [ Time Frame: From baseline to the end of treatment at visit 13 (day 169) ] [ Designated as safety issue: No ]
  • Creatinine clearance variation [ Time Frame: From baseline to the end of treatment at visit 13 (day 169) ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: July 2010
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group 1: insulin glargine + insulin glulisine
insulin glargine once daily + glulisine at meal times
Drug: INSULIN GLARGINE
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
Drug: INSULIN GLULISINE
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
Active Comparator: group 2 NPH insulin + regular insulin
NPH insulin (isophane insulin) (2 or more divided doses) + regular insulin at meal times
Drug: NPH insulin (insulin isophane)
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia
Drug: Regular insulin
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01122979

Locations
Brazil
Investigational Site Number 076-007
Curitiba, Brazil, 80060-900
Investigational Site Number 076-001
Fortaleza, Brazil, 60115-282
Investigational Site Number 076-010
Fortaleza, Brazil, 60015-052
Investigational Site Number 076-003
Porto Alegre, Brazil, 91350-250
Investigational Site Number 076-004
São Paulo, Brazil, 01323-001
Investigational Site Number 076-005
São Paulo, Brazil, 01244-030
Investigational Site Number 076-002
São Paulo, Brazil, 04024-002
Investigational Site Number 076-009
São Paulo, Brazil, o4039-000
Investigational Site Number 076-013
São Paulo, Brazil, 01308-050
Investigational Site Number 076-006
Taguatinga, Brazil, 72155000
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01122979     History of Changes
Other Study ID Numbers: LANTU_L_04737
Study First Received: May 11, 2010
Last Updated: November 7, 2013
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Glargine
Insulin glulisine
Insulin
Insulin, NPH
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014