This study will evaluate the safety and efficacy of Relamorelin compared to placebo in
patients with diabetic gastroparesis. Patients will report daily severity scores of their
diabetic gastroparesis symptoms.

Deficits in both the peripheral and central nervous systems are important complications found in people with Type 2 diabetes (T2D). Conditions such diabetic peripheral neuropathy (DPN) and slowing of the neural signals in the brain have been described in subjects with T2D, which are consistent with motor control and cognitive impairments observed in this population. A good cognitive and motor control is essential for manual function and dexterity such as drinking from a glass, buttoning a shirt, and, in case of people with diabetes, checking blood glucose levels or giving self-injections.

By doing this study, researchers hope to learn about the relationship between sitting time and different health measures, such as strength, endurance, blood sugar control, and fatigue.

 

The following is involved for those eligible to participate: 

- 7 days of wearing an activity monitor called ActivPAL (secured to your thigh with waterproof tap)

- Completing questionnaires about your activity and well-being

- Assessment of strength, endurance, balance, blood sugar control, and fatigue

The purpose of this study is to determine the safety and efficacy of bilateral intramuscular
injections of VM202 versus placebo in the treatment of painful diabetic neuropathy.

A total of 477 subjects will be randomized in a 2:1 ratio to one of two treatment groups:

Treatment - VM202 - 318 subjects Control - Placebo (VM202 vehicle) - 159 subjects

Randomization will be stratified by current use of gabapentin and/or pregabalin.

This study will compare two different exercise and diet programs for Type 2 diabetic patients with diabetic neuropathy. Half of participants will be assigned at random to receive the diet and exercise counseling, typically provided to patients with diabetes while the other half of participants will receive supervised exercise and activity counseling, together with more intensive diet counseling. The study's primary goal is to compare the change in the number of small nerves that reach to the surface of the skin, as measured by skin biopsy, between the two treatment groups.