Clinical Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LEZ763

Novartis

Status and phase: Completed; Phase 2; Phase 1

Conditions: Type II Diabetes

Treatments: Drug: LEZ763; Drug: Placebo; Drug: Sitagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01619332

CLEZ763X2201

Details and patient eligibility

About

This study is a three part study to assess the safety and efficacy of LEZ763 on normal healthy volunteers and patients with Type 2 Diabetes.

Enrollment: 220 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All subjects: (suggest this will reduce duplication)
• Male or female aged 18-65 yr,
• Subjects must weigh at least 50 kg to participate in the study. Body mass index (BMI) must be within the range of 18-37 kg/m2 (inclusive
• Only postmenopausal females or female subjects who report surgical sterilization (women without child bearing potential) will be allowed in this study.
• Subjects with stable conventional sleep-wake cycle

Normal Healthy Volunteers

• Healthy male or female subjects,
• must be in good health (as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at Screening).

Type II Diabetic Patients

• Type 2 diabetes diagnosed by American Diabetes Association criteria for at least 3 months prior to screening.
• Patients either drug naïve or on stable dose of metformin (stable dose for at least 4 weeks prior to Screening). The metformin dose should remain constant during the course of the study.
• HbA1c 6.5 to 9.5 % inclusive at screening

Exclusion criteria

All subjects:

• Smokers (use of tobacco products in the previous 3 months).
• Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
• Significant illness within two weeks prior to dosing.
• Have (or have history of) drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations

Normal Healthy Volunteers

• History of diabetes, or adrenal disorders.

Type II Diabetic Patients

• Type 1 diabetes mellitus; positive anti-GAD antibodies; acquired or secondary forms of diabetes such as those resulting from pancreatic surgery/injury, cystic fibrosis related diabetes
• Evidence of clinically significant diabetic complications (such nephropathy, retinopathy, neuropathy) Other protocol defined inclusion/exclusion criteria may apply

Trial design

220 participants in 3 patient groups, including a placebo group

LEZ763

Experimental group

Description:

Part I- Healthy volunteers enrolled into 6 single-ascending dose cohorts Part II- Healthy volunteers enrolled into 5 multiple-ascending dose cohorts. Part III- LEZ763 will be given orally once daily for 28 days in a randomized and blinded manner

Treatment:

Drug: LEZ763

Placebo

Placebo Comparator group

Description:

Part I : Healthy volunteers enrolled in 6 single ascending dose cohorts to receive matching placebo of LEZ763. Part II: Healthy volunteers enrolled in 5 multiple ascending dose cohorts to receive matching placebo of LEZ763. Part III- Placebo will be given orally once daily for 28 days to patients assigned to placebo in a randomized and blinded manner

Treatment:

Drug: Placebo

Sitagliptin

Active Comparator group

Description:

Sitaglitpin will be given orally once daily for 28 days to patients assigned to this treatment in a randomized and blinded manner

Treatment:

Drug: Sitagliptin