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A Phase 4 Study of Dulaglutide When Added to Insulin Treatment in Patients With Type 2 Diabetes

A Phase 4 Study of Dulaglutide When Added to Insulin Treatment in Patients With Type 2 Diabetes

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1080223318
Enrollment
Unknown
Registered
2016-09-13
Start date
2016-09-13
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Type 2 Diabetes

Interventions

investigational material(s) Generic name etc : Dulaglutide INN of investigational material : Therapeutic category code : 249 Other hormone preparations (including antihormone preparations) Dosage and

Sponsors

Eli Lilly Japan K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Participants who have had a diagnosis of type 2 diabetes mellitus. Participants who have been treated with insulin therapy (basal insulin, premixed insulin, or basal/mealtime insulin regimen) with or without 1 or 2 oral antidiabetics (OADs) at stable dose for at least 3 months before screening. Participants who have an HbA1c value (greater than or equal 7.0%) and (less than or equal 10.5%) at screening if the participant is washing out OADs (dipeptidyl peptidase-4 [DPP-4] inhibitors, sulfonylurea [SU], or glinides) or (greater than or equal 7.5%) and (less than or equal 10.5%) at screening if the participant is not washing out OADs. Participants who have stable weight (+-5%) (greater than or equal 3 months) prior to screening. Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kilogram per square meter).

Exclusion criteria

Exclusion criteria:

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026