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The Incidence of Hypoglycemia in Insulin Glargine-Treated Subjects With Diabetes Mellitus Upon Switching Between Bedtime and Morning Dosing

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00609895
First received: January 24, 2008
Last updated: March 26, 2008
Last verified: March 2008
  Purpose

To compare the percentage of subjects with a glucose measurement < than or = to 56 mg/dL at any point of the 8-point glucose profiles during 3 consecutive days before vs. 3 consecutive days after switching insulin glargine dosing time from bedtime to morning and vs. 3 consecutive days after switching back to bedtime dosing of insulin glargine.


Condition Intervention Phase
Diabetes Mellitus
Drug: INSULIN GLARGINE
Drug: Insulin Glargine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Incidence of Hypoglycemia in Insulin Glargine-Treated Subjects With Diabetes Mellitus Upon Switching Between Bedtime and Morning Dosing

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Compare % of subjects with glucose > or = to 56 mg/dL at any point of 8-point glucose profiles during 3 consecutive days [ Time Frame: before vs. after switching dosing time from bedtime to morning and vs. after switching back to bedtime ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare % subjects with glucose measurements < or = to 72 mg/dL & < or = to 36 mg/dL at any point of the 8-point glucose profile during 3 consecutive days [ Time Frame: before vs. after switching dosing time from bedtime to morning and vs. after switching back to bedtime ] [ Designated as safety issue: No ]
  • To compare the mean daily rate of hypoglycemia during 3 consecutive days [ Time Frame: before vs. after switching dosing time from bedtime to morning and vs. after switching back to bedtime ] [ Designated as safety issue: No ]
  • To compare the changes from baseline in glucose values at each specific measurement time of the 8-point glucose profile during 3 consecutive days [ Time Frame: before vs. after switching dosing time from bedtime to morning and vs. after switching back to bedtime ] [ Designated as safety issue: No ]
  • To compare the incidence of symptomatic hypoglycemia [ Time Frame: at any time during 3 consecutive days before vs. after switching dosing time from bedtime to morning and vs. after switching back to bedtime ] [ Designated as safety issue: No ]
  • To evaluate overall safety and tolerability based on adverse event reporting, laboratory tests, and clinical examinations [ Time Frame: at any time during the study ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: January 2004
Study Completion Date: August 2004
Intervention Details:
    Drug: INSULIN GLARGINE Drug: Insulin Glargine
    Other Name: Lantus
  Eligibility

Ages Eligible for Study:   6 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 or type 2 diabetes mellitus diagnosis for at least 1 year Administration of insulin glargine for at least 2 months prior to screening; subjects must be on a stable dose of insulin glargine, + or - 15%, for at least 1 week prior to screening, given once daily at bedtime, and the dose must remain unchanged (+ or - 15%) during the screening period.
  • If subjects are taking a short-acting insulin (e.g., regular human insulin, insulin lispro, or insulin aspart) or oral antidiabetic agents (e.g., a sulfonylurea, metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, or a metiglinide), the subject must have been receiving these medications for at least 2 months prior to screening.
  • For subjects taking an oral antidiabetic agent, the dose must be unchanged for the 2 weeks (4 weeks for a thiazolidinedione) prior to screening and should not be expected to be changed from the screening visit (day 14) through the final visit (day 11). The dose of any short-acting insulin may be changed if medically indicated.
  • Males or non-pregnant females between the ages of 6 and 75 years; women must be postmenopausal for more than 2 years, surgically sterile, or agree to use a reliable contraceptive measure for the duration of the study. Reliable contraceptive measures include the following: systemic contraceptive (oral, implant, injections), diaphragm with intravaginal spermicide, cervical cap, intrauterine device, or condom with spermicide.
  • Ability and willingness to perform blood glucose profiles using a plasma glucose meter provided at home over 11 consecutive days.
  • HbA1c < than or = to 8.5% at screening.

Exclusion Criteria:

  • Use of any other intermediate- or long-acting insulin (e.g., NPH, Ultralenter, Lenter) within the last 2 months prior to screening.
  • Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol (e.g., systemic corticosteroids).
  • History of hypoglycemia unawareness.
  • Pregnancy (as determined by a serum pregnancy test at the screening visit).
  • Breast-feeding.
  • Treatment with any investigational drug in the 2 months prior to the screening visit.
  • Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult.
  • History of drug or alcohol abuse.
  • Impaired hepatic function, as shown by but not limited to serum glutamic-oxaloacetic transaminase (SGPT, also known as alanine transaminase [ALT]) or serum glutamic-pyruvic transaminase (SGOT, also known as aspartate transaminase [AST]) above 2x the upper limit of normal range (ULN) measured at the screening visit.
  • Impaired renal function, as shown by, but not limited to serum creatinine > than or = to 1.5 mg/dL (133 micromol/L) [males] or > than or = to1.4 mg/dL (124 micromol/L) [females] measured at the screening visit. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.
  • Subjects who work the night shift.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00609895

Locations
Mexico
Sanofi-Aventis
Monterrey, Mexico
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Judith Diaz Sanofi
  More Information

No publications provided

Responsible Party: Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00609895     History of Changes
Other Study ID Numbers: HOE901_4038
Study First Received: January 24, 2008
Last Updated: March 26, 2008
Health Authority: Mexico: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Hypoglycemia
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glargine
Insulin
Insulin, Globin Zinc
Insulin, Long-Acting
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014