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OBSERVATIONAL RESEARCH PROGRAM TO TRANSFER PATIENTS FROM REGULAR INSULIN + INSULIN NPH TO HUMALOG + HUMULIN N FOR THE TREATMENT OF DIABETES MELLITUS

OBSERVATIONAL RESEARCH PROGRAM TO TRANSFER PATIENTS FROM REGULAR INSULIN + INSULIN NPH TO HUMALOG + HUMULIN N FOR THE TREATMENT OF DIABETES MELLITUS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-017-01
Enrollment
Unknown
Registered
2001-04-27
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Group 1 Type of group
The doses will be calculated according to the levels of glycemia. Patients will be transferred from Regular Insulin + NPH Insulin to Humalog + Humulin N in equivalent amounts. The treatment will last 4 weeks.

Sponsors

ELI LILLY INTERAMERICA INC.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of both sexes diagnosed with Diabetes Mellitus type 1 or 2 who require insulin as defined by the WHO Diagnostic criteria (Annex S009-2) and who are already receiving Regular Insulin + NTH Insulin will be considered eligible to be enrolled in this program .

Exclusion criteria

Exclusion criteria: NA

Design outcomes

Primary

MeasureTime frame
Outcome name:Fasting and postprandial blood glucose Measure:Change in the level of Blood Glucose Timepoints:4 and 8 weeks

Secondary

MeasureTime frame
Outcome name:Measurement of HbA1 (glycosylated hemoglobin) Measure:Change in the levels of Glycosylated hemoglobin Timepoints:Week 0 and 8 ; Outcome name:A hypoglycemic episode is defined as any episode in which the patient feels, or another person observes, that he / she is experiencing a sign / symptom associated with hypoglycemia, or a blood glucose measurement less than 54 mg / dL. Measure:Appearance Hypoglycemic episodes Timepoints:Weeks 0, 4 and 8 ; Outcome name:Registry of adverse events Measure:Safety Timepoints:When the event happens

Outcome results

None listed

Source: REPEC (via WHO ICTRP)