A Comparison of Two Treatment Strategies in Older Participants With Type 2 Diabetes Mellitus (T2DM)

Part of paid clinical trials in Miami, Florida.

Sponsor
Eli Lilly and Company
Study ID
NCT02072096
Phase
PHASE4
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Glimepiride — DRUG
    Administered orally
  • Metformin — DRUG
    Administered orally
  • Pioglitazone — DRUG
    Administered orally
  • Acarbose — DRUG
    Administered orally
  • Linagliptin — DRUG
    Administered orally
  • Sitagliptin — DRUG
    Administered orally
  • Liraglutide — DRUG
    Administered subcutaneously (SC)
  • Insulin Glargine — DRUG
    Administered SC
  • Exenatide once weekly (QW) — DRUG
    Administered SC
  • Exenatide twice daily (BID) — DRUG
    Administered SC

Study Details

The main purpose of this study is to compare the benefits and risks associated with the use of 2 treatment strategies to lower blood sugar in participants aged 65 and older with T2DM. One strategy is based on the use of oral and injectable medications that only reduce blood sugar (glucose) when it is high. The other strategy is based on non-glucose dependent agents. The trial will last up to 72 weeks for each participant.

Key Dates

Start date
Feb 28, 2014
Status verified
Sep 2019
Primary completion
Oct 31, 2015
Completion
Oct 31, 2015

Study Design

Enrollment
192 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Strategy A (Glucose-Dependent)
    Participants may receive oral and injectable (glucagon-like peptide-1 receptor agonists \[GLP-1 RA\]) therapies that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
  • Active Comparator: Strategy B (Reference)
    Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Insulin glargine is titrated according treatment algorithm. Treatment may last up to 72 weeks.

Primary Outcome Measure

Percentage of Participants Achieving and Maintaining Individualized Glycated Hemoglobin A1c (HbA1c) Targets Without Clinically Significant Hypoglycemia [ Time Frame: Baseline to last participant visit (up to 72 weeks) ]

Locations (16)

FacilityCityStateZIPSite coordinators
New Horizon Research CenterMiamiFlorida33175-
Suncoast Research Group, LLCMiamiFlorida33135-
Suncoast Clinical ResearchNew Port RicheyFlorida34652-
Florida HospitalOrlandoFlorida32804-
Athens Primary CareAthensGeorgia30606-
Herman Clinical Research, LLCSuwaneeGeorgia30024-
Rocky Mountain Diabetes and Osteoporosis CenterIdaho FallsIdaho83404-
Iderc, P.L.C.Des MoinesIowa50314-
Cotton O'Neil ClinicTopekaKansas66606-
Mercy Health ResearchSt LouisMissouri63141-
Southern New Hampshire Diabetes and EndocrinologyNashuaNew Hampshire03063-
Heritage Valley Medical Group, Inc.BeaverPennsylvania15009-
Family Medical AssociatesLevittownPennsylvania19056-
Carolina Health SpecialistsMyrtle BeachSouth Carolina29572-
Dallas Diabetes Endocrine CenterDallasTexas75230-
Rockwood Clinic Research CenterSpokaneWashington99202-

Find similar trials in Miami, FL

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
New Horizon Research Center· Miami, FLSuncoast Research Group, LLC· Miami, FLSuncoast Clinical Research· New Port Richey, FLFlorida Hospital· Orlando, FLAthens Primary Care· Athens, GAHerman Clinical Research, LLC· Suwanee, GA

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