A Study of Lispro Formulations in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Lispro

Study type: Interventional

Funder types: Industry

Identifiers

NCT02293551

15626

F3Z-FW-ITCA (Other Identifier)

Details and patient eligibility

About

The purposes of this study are to determine:

• Part A

  • How quickly your body absorbs, breaks down and gets rid of the different formulations of insulin lispro compared to insulin lispro alone formulation.
  • The safety of insulin lispro in different formulations and any side effects that might be associated with it.

• Part B:

  • How much insulin lispro from different dose ranges is found in the bloodstream using a test insulin lispro formulation (selected from Part A).
  • The safety of insulin lispro in different formulations and any side effects that might be associated with it.

Participants may only enroll in one part. The study is expected to last up to 10 weeks for each part.

Enrollment: 54 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

- Overtly healthy males or females (non-childbearing potential and with absent cyclical hormonal changes), as determined by medical history and physical examination

Exclusion criteria

- Have a fasting plasma glucose less than or equal to (≤) 4.0 millimole per liter (mmol/L) at screening

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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54 participants in 6 patient groups

Part A: Lispro (A)

Experimental group

Description:

Formulation A: Single dose of lispro administered subcutaneously (SC) in one of five periods.

Treatment:

Drug: Lispro

Part A: Lispro (B)

Experimental group

Description:

Formulation B: Single dose of lispro administered SC in one of five periods.

Treatment:

Drug: Lispro

Part A: Lispro (C)

Experimental group

Description:

Formulation C: Single dose of lispro administered SC in one of five periods.

Treatment:

Drug: Lispro

Part A: Lispro (D)

Experimental group

Description:

Formulation D: Single dose of lispro administered SC in one of five periods.

Treatment:

Drug: Lispro

Part A: Lispro (Reference)

Experimental group

Description:

Reference formulation: Single dose of lispro administered SC in one of five periods.

Treatment:

Drug: Lispro

Part B: Lispro

Experimental group

Description:

Formulation selected from Part A. Single dose of lispro administered SC in one of four periods.

Treatment:

Drug: Lispro