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Completed

NCT Number: NCT00099515

Comparing Intensive and Standard Training for Human Insulin Inhalation Powder (HIIP)

The purpose of this study is to compare intensive and standard training for human insulin inhalation powder in patients with type 2 diabetes.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Sante Fe, Rosario, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 diabetes for at least 12 months
  • Age 18 or older.
  • Taking at least 1 oral antihyperglycemic medication.
  • Have an HbA1C between 7.5 and 12.
  • Be a nonsmoker

Exclusion criteria

  • Body Mass Index (BMI) greater than 40.
  • Have frequent episodes of severe hypoglycemia.
  • Have advanced autonomic neuropathy.
  • Have history of asthma.
  • Have chronic obstructive pulmonary disease (COPD).

Treatment and study plan

LY041001 (HIIP)

Drug

Inhalation, capsule, TID 3 times per day min 6 IU max 60 IU

Primary outcomes

  1. Hypothesis that std training for HIIP system is noninferior to intensive training by 1.2 mmol/L with respect to overall 2-hr postprandial glucose excursion of (SMBG) in type 2 diabetes patients that have been on preprandial trmt with HIIP

    Time frame: 4 weeks

Secondary outcomes

  1. Assess the suitability of the HIIP delivery system for type 2 diabetes patients

    Time frame: 4 weeks

  2. Compare the SMBG profiles of preprandial HIIP administration with standard training and with intensive training Assess patient compliance with the HIIP delivery system Directions for Use (DFU) provided by the Sponsor with and without intensive training

    Time frame: 4 weeks

  3. Compare the test meal blood glucose profiles of preprandial HIIP administration with standard training and with intensive training

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Alkermes, Inc.

Registry information

Official study title

Standard Training Versus Intensive Training for HIIP Delivery System Usage in Insulin-Naïve Patients With Type 2 Diabetes Mellitus

Acronym: IDAP

Important dates

Study start
2004
Study completion
2005
First posted
Dec 16, 2004
Registry last updated
Dec 21, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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