Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Insulin (IN-105) in Type 1 Diabetes Patients

NCT01035801 | Terminated Phase 1

• 1 other identifier: IN105-CT1-005-09
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to see whether IN-105 (oral insulin) is able to control increase in blood glucose after eating a meal. This study will also tell whether single tablet of IN-105 is safe for patients with Type 1 diabetes mellitus who are currently taking insulin injections.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• AUC (Insulin and Blood Glucose)

  0-130 min

Secondary Outcomes (2)

• AUC (Insulin and Blood Glucose)

  0-70 min, 0-190 min and 0-250 min

• Frequency of Adverse Events

  9 weeks

Study Arms (2)

IN105

EXPERIMENTAL

Prandial Oral Insulin

Drug: IN-105

Insulin Lispro Injection

ACTIVE COMPARATOR

Drug: Insulin Lispro Injection

Interventions

IN-105 DRUG

Prandial Oral Insulin

IN105

Insulin Lispro Injection DRUG

Insulin Lispro Injection

Insulin Lispro Injection

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female patients between the ages of 18-45 years inclusive
• Established diagnosis of T1DM for at least 1-year
• Body mass index of 18.5-29.9 kg/m2 inclusive
• Stable weight with no more than 5 kg gain or loss within 3 months of screening
• HbA1c ≤ 8.0%
• On stable insulin or an insulin analogue regimen for at least 3 months

You may not qualify if:

• Any hypersensitivity or allergy
• Positive urine ketones test at screening visit.
• ECG abnormality
• total daily insulin \>1 IU/kg and/or \>0.7 IU/Kg of basal insulin and/or \>0.6 IU/Kg of prandial insulin.
• Patient with a clinically significant abnormality
• Evidence of severe secondary complications of diabetes
• History of drug or alcohol dependence or abuse
• Patients currently on systemic or inhaled glucocorticoids or other drugs, which may affect glycemic control.
• Patients treated with blood-glucose lowering drugs other than insulin or insulin analogues in the last 4 weeks prior to screening or during the study
• History of two or more severe episodes of hypoglycemia (defined by ADA criteria) within 6 months prior to screening and/or patients with history of low blood glucose level episodes suggestive of hypoglycemia unawareness (loss of warning symptoms of hypoglycemia). Investigator to assess this criterion based on the subject filled questionnaire.
• Any hospitalization or emergency room visit due to poor diabetes control within 6 months prior to screening.
• Impaired hepatic function (ALT or AST value greater than 2 X Upper limit of reference range and/or serum bilirubin ≥1.5 X Upper limit of reference range at the screening visit).
• Impaired renal function (serum creatinine ≥1.5 X Upper limit of reference range at screening).
• Hemoglobinopathies, haemolytic anaemia, anaemia of chronic disease, or any factor affecting the measurement of HbA1c.
• Any electively planned surgery requiring hospitalization during the study period.

Sponsors & Collaborators

• Biocon Limited: lead

Study Sites (5)

Care Hospital

Hyderabad, Andhra Pradesh, 500034, India

Location

Bharti Research Institute of Diabetes and Endocrinology

Karnāl, Haryana, 132001, India

Location

Diacon Hospital,(Diabetes Care and Research Centre)

Bangalore, Karnataka, 560010, India

Location

Bangalore Diabetes Hospital

Bangalore, Karnataka, 560052, India

Location

Belgaum Diabetic Centre

Belagavi, Karnataka, 590001, India

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Indium-105; Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Dr. K.M. Prasanna Kumar, MD, DM

  CEO and Consultant Endocrinologist, Bangalore Diabetes Hospital, #16/M, Miller tank Bed Area, Thimmaiah Road, Vasanthnagar, Bangalore-560052

  PRINCIPAL INVESTIGATOR

• Dr. Aravind R Sosale, DNB

  Director, Diacon Hospital,Diabetes Care and Research Centre, 359-360, 19th Main, Ist Block,Rajajinagar,Bangalore-560010.

  PRINCIPAL INVESTIGATOR

• Dr. Sanjay Kalra, MD, DM

  Bharti Research Institute of Diabetes & Endocrinology (BRIDE), Bharti Hospital, Wazir Chand Colony, Kunjpura, karnal, Hariyana- 132001

  PRINCIPAL INVESTIGATOR

• Dr Bipin Kumar Sethi, MD, DM

  Care Hospital, Road 1, Banjara Hills, Hyderabad - 500034

  PRINCIPAL INVESTIGATOR

• Dr. Neeta Deshpande, MD

  Belgaum Diabetic Centre, Ground floor,Beside mahila Vastu Bhander, Maruti Gali, Belgaum- 590001

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2009
• First Posted: December 21, 2009
• Study Start: August 21, 2010
• Primary Completion: March 12, 2011
• Study Completion: March 12, 2011
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

IN (5)