Lantus in Prediabetes

Assessment of Safety and Tolerability of Lantus® (Insulin Glargine) in Subjects With Impaired Fasting Glucose (IFG) or Impaired Glucose Tolerance (IGT)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00348972

Enrollment

Registered

2006-07-06

Start date

2002-02-28

Completion date

Unknown

Last updated

2006-07-06

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

Conditions

Diabetes Mellitus, Hyperglycemia

Keywords

Glargine, prediabetes, impaired glucose tolerance, impaired fasting glucose

Brief summary

To assess the safety, tolerability, and efficacy of Lantus® (insulin glargine) in prediabetes (IFG or IGT).

Interventions

DRUGLantus® (insulin glargine)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* Hyperglycemia (either IGT , IFG, or untreated type 2 diabetes) * HbA1c \< 7.0% * BMI \< 40kg/m2 * Able to perform moderate stationary bicycle exercise

Exclusion criteria

* Chronic pharmacologic treatment for hyperglycemia, past or present * CAD * serum creatinine \> 2.0mg/dL * BP \> 180/105 * History of hypoglycemia unawareness

Design outcomes

Primary

Measure	Time frame
Efficacy: 8-point blood glucose measurements.	—
Safety / tolerability: hypoglycemia	—

Secondary

Measure	Time frame
Blood glucose in response to exercise.	—
Fasting supine levels of counterregulatory hormones	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026