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Type 1 Diabetes MellitusPhase 1NCT01035801

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

A Phase 1 study testing IN-105 and Insulin Lispro Injection in people with Type 1 Diabetes Mellitus, run by Biocon Limited at 5 sites in India.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
IN-105 and Insulin Lispro Injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
5 sitesIndia
Study dates
21 Aug 2010to 12 Mar 2011
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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.
  • Pregnancy, lactation, or planned pregnancy during the study duration.
  • The patient has received another investigational drug within 6 weeks prior to screening
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

India5 sites

  • Diacon Hospital,(Diabetes Care and Research Centre)

    Bangalore, Karnataka, 560010

  • Bangalore Diabetes Hospital

    Bangalore, Karnataka, 560052

  • Belgaum Diabetic Centre

    Belagavi, Karnataka, 590001

  • Care Hospital

    Hyderabad, Andhra Pradesh, 500034

  • Bharti Research Institute of Diabetes and Endocrinology

    Karnāl, Haryana, 132001

Other trials in India

About this study

Official title: An OpenLabel, Multicenter, Non-randomized, ActiveControlled, SingleDose Escalation, Study to Evaluate the Pharmacodynamics,Pharmacokinetics,Safety, and Tolerability of IN-105 Under Fed Conditions In Patients With Type 1 Diabetes Mellitus

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.

Being tested
IN-105, Insulin Lispro Injection
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IN-105Drug

    Prandial Oral Insulin

  • Insulin Lispro InjectionDrug

    Insulin Lispro Injection

Study groups in NCT01035801
Study groupRoleWhat they receive
IN105ExperimentalPrandial Oral Insulin
Receives: Drug: IN-105
Insulin Lispro InjectionActive comparatorNot described
Receives: Drug: Insulin Lispro Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUC (Insulin and Blood Glucose)

    Measured: 0-130 min

Secondary outcomes (2)

  1. AUC (Insulin and Blood Glucose)

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

  2. Frequency of Adverse Events

    Measured: 9 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2009 (estimated)
  2. Study start21 Aug 2010
  3. Primary completion12 Mar 2011
  4. Study completion12 Mar 2011

Why it stopped: This study was temporarily paused due to an unanticipated bioanalytical issue.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01035801
Sponsor's protocol ID
IN105-CT1-005-09
Status last verified
Jan 2018
First submitted
18 Dec 2009
Last updated
23 Jan 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IN-105 and Insulin Lispro Injection in people with Type 1 Diabetes Mellitus, run by Biocon Limited at 5 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: This study was temporarily paused due to an unanticipated bioanalytical issue.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC (Insulin and Blood Glucose) (time frame: 0-130 min). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01035801.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.

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