Type 2 DiabetesPhase 2NCT01264497
Safety Study of TH9507 in Subjects With Stable, Type 2 Diabetes
A Phase 2 study testing TH9507 in people with Type 2 Diabetes, run by Theratechnologies.
Trial summary
The purpose of this study was to determine whether TH9507, a stabilized analogue of growth hormone-releasing factor (GRF), would have an effect on insulin sensitivity or control of diabetes in patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- TH9507
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Feb 2002to Nov 2002
- Phase
- Phase 2
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or postmenopausal or surgically sterilized female subjects, 50 years of age or older;
- Documented diagnosis of type 2 diabetes as defined by the American Diabetes Association;
- Diagnosis of type 2 diabetes for at least 3 months before screening;
- Subjects on stable diabetes treatment regimens (receiving oral hypoglycemics with or without insulin) for at least 2 months before screening;
- Screening and pre-randomization glycosylated hemoglobin (HbA1c) <10.0%, according to central laboratory;
- Body mass index (BMI) between 25 and 38 kg/m2
- Subjects willing to perform specified home blood glucose monitoring and comply with all study protocol requirements;
- Signed informed consent.
Who cannot join
- Serum creatinine >2 mg/dL;
- Fasting triglycerides >1000 mg/dL;
- Albuminuria >200 mg/24 hours;
- Positive mammography (if female) or prostate-specific antigen (PSA) or prostate examination for cancer (if male);
- Use of oral or parenteral glucocorticoids in the 30 days before screening;
- Use of any experimental or marketed growth hormone, growth hormone secretagogues, insulin-like growth factor-1 (IGF-1), or insulin-like growth factor binding protein-3 (IGFBP-3) during the previous 6 months;
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- Subjects with two or more severe hypoglycemia episodes within the past 6 months, or any hospitalization or emergency room visit due to poor glycemic control within the past 6 months. Similarly, during the lead-in period, any subject with more than one severe hypoglycemic episode or any hospitalization or emergency room visit due to poor glycemic control will be excluded from randomization;
- History of or presence of active concomitant conditions or diseases (e.g., myocardial infarction, poorly controlled hypertension, thyroid disease, rheumatoid arthritis, seizure disorder, diabetic neuropathy, diabetic retinopathy [except subjects with only microaneurysms on fundus examination]) that would interfere with the protocol conduct and endpoint measurements;
- Subjects with a major surgical operation during the 30 days before screening;
- Subjects with known hypopituitarism, history of pituitary tumor/surgery, head irradiation, or severe head trauma;
- Current cancer or history of cancer, except non-melanomatous skin cancer;
- Subjects with active infection at any body site or a history of severe infection (requiring oral or parenteral treatment) during the 30 days before screening;
- Subjects with clinically significant abnormalities on screening laboratory evaluation (unless discussed with and approved by the medical monitor);
- Subjects with allergy to synthetic growth hormone products or their excipients;
- Subjects who had previously received growth hormones in any clinical trial;
- Participation in a trial of an experimental drug or device within 90 days before screening.
About this study
Official title: A Double-blind, Randomized, Parallel, Placebo-controlled 12-week Evaluation of the Safety of Two Doses of TH9507 in Subjects With Stable, Type 2 Diabetes Mellitus
The purpose of this study was to determine whether TH9507, a stabilized analogue of growth hormone-releasing factor (GRF), would have an effect on insulin sensitivity or control of diabetes in patients with type 2 diabetes.
- Conditions
- Type 2 Diabetes
- Being tested
- TH9507
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TH9507Drug
1 and 2 mg, sc daily for 12 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in relative insulin response
Secondary outcomes (4)
Change from baseline in glycosylated hemoglobin (HbA1c)
Change in mean daily serum glucose concentrations
Home blood glucose will be obtained four times per day (before breakfast, lunch, and dinner, and at bedtime) using a standard blood glucose meter
Changes in the number of dose adjustments per week for insulin and/or oral hypoglycemic agents
Number of subjects with a change in the control of diabetes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study startFeb 2002
- Primary completionNov 2002
- Study completionNov 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theratechnologies
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264497
- Sponsor's protocol ID
- TH9507/II/Diabetes/006
- Status last verified
- Dec 2010
- First submitted
- 17 Dec 2010
- Last updated
- 21 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Clemmons DR, Miller S, Mamputu JC. Safety and metabolic effects of tesamorelin, a growth hormone-releasing factor analogue, in patients with type 2 diabetes: A randomized, placebo-controlled trial. PLoS One. 2017 Jun 15;12(6):e0179538. doi: 10.1371/journal.pone.0179538. eCollection 2017.
PubMed 28617838
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Parallel, Placebo-controlled 12-week Evaluation of the Safety of Two Doses of TH9507 in Subjects With Stable, Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01264497
- Acronym / sponsor ID
- TH9507/II/Diabetes/006
- Conditions
- Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- TheratechnologiesIndustry (pharma, biotech, devices)
- Study start
- Feb 2002
- Primary completion
- Nov 2002 (actual)
- Study completion
- Nov 2002 (actual)
- First posted
- 21 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to determine whether TH9507, a stabilized analogue of growth hormone-releasing factor (GRF), would have an effect on insulin sensitivity or control of diabetes in patients with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or postmenopausal or surgically sterilized female subjects, 50 years of age or older;
- Documented diagnosis of type 2 diabetes as defined by the American Diabetes Association;
- Diagnosis of type 2 diabetes for at least 3 months before screening;
- Subjects on stable diabetes treatment regimens (receiving oral hypoglycemics with or without insulin) for at least 2 months before screening;
- Screening and pre-randomization glycosylated hemoglobin (HbA1c) <10.0%, according to central laboratory;
Key exclusion criteria (16 listed)
- Serum creatinine >2 mg/dL;
- Fasting triglycerides >1000 mg/dL;
- Albuminuria >200 mg/24 hours;
- Positive mammography (if female) or prostate-specific antigen (PSA) or prostate examination for cancer (if male);
- Use of oral or parenteral glucocorticoids in the 30 days before screening;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TH95071 and 2 mg, sc daily for 12 weeks | Drug | – |
Primary outcome
Change from baseline in relative insulin response
4 secondary outcomes
Change from baseline in glycosylated hemoglobin (HbA1c)
Change in mean daily serum glucose concentrations
Changes in the number of dose adjustments per week for insulin and/or oral hypoglycemic agents
Number of subjects with a change in the control of diabetes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2010.
- Derived from this study: PubMed 28617838Clemmons DR, Miller S, Mamputu JC. Safety and metabolic effects of tesamorelin, a growth hormone-releasing factor analogue, in patients with type 2 diabetes: A randomized, placebo-controlled trial. PLoS One. 2017 Jun 15;12(6):e0179538. doi: 10.1371/journal.pone.0179538. eCollection 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TH9507 in people with Type 2 Diabetes, run by Theratechnologies.
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 8 inclusion and 16 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: finished, as of the sponsor's last update on 21 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in relative insulin response. 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 NCT01264497, which also lists 1 linked publication.
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 21 Dec 2010.