Pilot Study to Assess Adherence to a Novel Eating System in Men and Women With Type 2 Diabetes Mellitus

Inclusion criteria

• Male or female, 18-79 years of age, inclusive.
• Diagnosis of type 2 diabetes, at least nine months prior to screening.
• Stable use of oral hypoglycemic medication for at least two months prior to screening.
• Body mass index (BMI) ≥25.0 and <45.0 kg/m2 at screening.
• Willingness to follow a novel eating plan, which may be energy restricted to promote weight loss, throughout the trial.

Exclusion criteria

• History or diagnosis of type 1 diabetes mellitus.
• Poorly controlled type 2 diabetes mellitus (HbA1C ≥9.0%).
• Weight loss or gain >10 lb (4.5 kg) in the two months prior to screening.
• Abnormal laboratory test results of clinical importance.
• History of gastrointestinal surgery for weight-reducing purposes.
• Poorly controlled hypertension.
• A clinically important medical or other condition.
• Any major trauma or major surgical event within three months of screening.
• Use of injected medications for glucose control within four weeks prior to screening.
• Use of weight loss medications, supplements, programs, or meal replacement products within two months of screening.
• Unstable use of foods, dietary supplements, herbals or medications, other than allowed medications, that have the potential to influence carbohydrate or lipid metabolism.
• Pregnancy
• Any history of extreme eating habits or an eating disorder diagnosed by a health professional.
• Recent history of (within 12 months of visit 1) or strong potential for alcohol or substance abuse.