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Clinical Trials/EUCTR2013-001473-24-DE
EUCTR2013-001473-24-DE
Active, not recruiting
Not Applicable

An Individualized treatMent aPproach for oldER patIents: A randomized, controlled stUdy in type 2 diabetes Mellitus - IMPERIUM

Eli Lilly and Company0 sites880 target enrollmentDecember 2, 2013
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ConditionsDiabetes Mellitus, Type 2MedDRA version: 16.1Level: LLTClassification code 10063624Term: Type II diabetes mellitus inadequate controlSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 2
Sponsor
Eli Lilly and Company
Enrollment
880
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 2, 2013
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •The study will include patients who are:
  • •Patients with T2DM based on a history and clinical impression that is consistent with the World Health Organization \[WHO] Classification of Diabetes
  • •Male or female
  • •Are at least 65 years of age at the time of screening
  • •Have a CFS of 4 or above AND/OR TIBI score of 5 or above as assessed at Visit 1
  • •Have an A1c \>7\.3% and \<10\.9% at study entry and are not achieving desired glycemic control as evidenced by A1c measurement at least 0\.4% higher than individualized treatment target set at Visit 1\.
  • •Have been treated for at least 3 months prior to the study entry with any of the following treatment options:
  • •odiet/exercise only (only if they have known contraindications to metformin treatment)
  • •oany dose of sulfonylurea
  • •oeffective or maximally tolerated doses of metformin, dipeptidyl\-peptidase\-4 (DPP\-4\) inhibitor, thiazolidinedione, or acarbose used in monotherapy or in dual combination. The following doses are considered to be effective:

Exclusion Criteria

  • •Patients will be excluded from the study based on the following criteria:
  • •Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
  • •Are Lilly employees or are employees of third\-party organizations (TPOs) involved in study who require exclusion of their employees
  • •Are currently enrolled in a clinical trial involving an investigational product or nonapproved use of a drug or device (other than the investigational product used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
  • •Have participated, within the last 60 days in a clinical trial involving an investigational product other than the investigational product used in this study. If the previous investigational product has a long half life, 3 months or 5 half\-lives (whichever is longer) should have passed
  • •Have previously completed or withdrawn from this study. This exclusion criterion does not apply to patients who are rescreened prior to randomization.
  • •At study entry have contraindications to sulfonylurea, insulin, or GLP\-1 RA
  • •Have a history of pancreatitis, a personal or family history of medullary thyroid carcinoma, or have Multiple Endocrine Neoplasia syndrome type 2
  • •Have taken any injectable glucose\-lowering agent, miglitol, meglitinide, Sodium/Glucose cotransporter\-2 inhibitor, or other antihyperglycemia treatment that is not listed in inclusion criterion \[6] (main protocol) for more than 10 days within 3 months prior to the study entry
  • •In the opinion of investigator should have an individualized A1c target set at 8% or higher

Outcomes

Primary Outcomes

Not specified

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