A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety and Tolerability of ITCA 650 in Patients with Type 2 Diabetes. ITCA 650-CLP-103

Study ID
STU 102012-089

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Daytheon Sturges
214-648-8848
daytheon.sturges@utsouthwestern.edu

Principal Investigator
Philip Raskin

Summary

This is a Phase 3, multicenter, randomized, doubleblind, placebo-controlled study to be conducted in
approximately 175 sites. approximately 450 subjects will be randomized 1:1:1 to treatment with iTCa
650 or matching iTCa placebo. Subjects will be treated for 39-weeks.

* Group 1: iTCa 650 40 mcg/day following an introductory dose of iTCa 650 20 mcg/day
* Group 2: iTCa 650 60 mcg/day following an introductory dose of iTCa 650 20 mcg/day
* Group 3: iTCa placebo

Group 1 will initially be treated with iTCa 650 20 mcg/day for 13 weeks. after 13 weeks iTCa 650 20
mcg/day will be replaced with iTCa 650 40 mcg/day for 26 weeks. at Week 39 the iTCa 650 40 mcg/day
device will be removed.

Group 2 will initially be treated with iTCa 650 20 mcg/day for 13 weeks. after 13 weeks iTCa 650 20
mcg/day will be replaced with iTCa 650 60 mcg/day for 26 weeks. at Week 39 the iTCa 650 60 mcg/day
device will be removed.

Group 3 will have an iTCa placebo placed for 13 weeks. at Week 13 the iTCa placebo will be replaced with a new iTCa placebo for 26 weeks. at Week 39 the iTCa placebo will be removed.

The total treatment duration is 39 weeks. all patients are required to return 4 weeks after their end of treatment (eT) for a post-treatment Follow-up assessment regardless of the reason for treatment cessation.

unless clinically indicated, oral background treatment for type 2 diabetes should not be modified during the study. Patients who experience hyperglycemia may be prescribed rescue treatment.

Background therapy should not be reduced after the occurrence of isolated symptoms or episodes of hypoglycemia evident in self-monitored blood glucose (SMBG) or laboratory results.

Participant Eligibility

1. Understanding of the study procedures and agreement to participate in the study by giving written informed consent at or prior to Screening;
2. Men or women age 18 to 80 years, inclusive;
3. Diagnosis of type 2 diabetes for >=3 months prior to Screening;
4. On a stable (>=3 months prior to Screening) treatment regimen of diet and exercise alone or in combination with a stable (>=3 months prior to Screening) and optimal or near-optimal dose of:

* SU monotherapy, or

* TZD(thiazolidinediones, a class of medications used in the treatment of type 2 diabetes) monotherapy, or

* combination therapy with SU + TZD, or

* combination therapy with SU + metformin, or

* combination therapy with TZD + metformin, or

* combination therapy with SU + TZD + metformin;
5. Agreement to maintain the same dose(s) of background medication from Screening to the end of study; at the Investigator[Single Quote]s discretion, the dose of SU can be lowered at randomization in order to avoid hypoglycemia;
6. HbA1c >=7.0% and <=10.0% at Screening. One re-test of this parameter is allowed prior to randomizaton;
7. Stable body weight (not varying by >10% for 3 months before Screening);
8. Calcitonin <50 ng/L (50 pg/mL) at Screening;
9. Body mass index (BMI) >=25 kg/m2 and <=45 kg/m2 at screening;
10. Women may be enrolled if all of the following criteria (in addition to other criteria) are met:

* they are not pregnant,

* they are not breast feeding, and

* they do not plan on becoming pregnant during the study;
11. Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening. Women are considered to be of childbearing potential unless they meet one of the following criteria as documented by the Investigator:

* they have had a hysterectomy or tubal ligation prior to signing the informed consent form; or

* they are post-menopausal, defined for women <=50 years old as >=2 years since their last menstrual period and for women >50 years old as >=1 year since their last menstrual period, or have a follicle-stimulating hormone (FSH) level in the menopausal range;
12. WOCBP must agree to use an adequate method of contraception during the study and for one additional menstrual cycle following the ET Visit. Women practicing abstinence or whose partner(s) is (are) sterile should be considered to be of childbearing potential. Adequate methods of contraception for WOCBP include: oral, implanted or injectable contraceptive hormones; mechanical products (e.g., IUD); or barrier methods (e.g., diaphragm, condoms, cervical cap) with spermicide. The patient[Single Quote]s understanding of this requirement must be documented by the Investigator.