Review question/objective This review will be guided by the following main research question: Is the use of bitter melon an effective and safe alternative to traditional hypoglycemic agents for reducing fasting blood sugar in patients with type 2 diabetes mellitus? Additional questions that will be addressed, with data permitting, are: Does the efficacy and safety of bitter melon vary by frequency of consumption and dosage (amount consumed)? Does the efficacy and safety of bitter melon differ by form of administration/consumption (for example, eating bitter melon versus drinking as a tea/diluting in water)? Does the efficacy and safety of bitter melon differ in some sub-groups within this population of patients with type 2 diabetes, such as sex and age groups or groups with other chronic diseases and co-morbidities? Inclusion criteria Types of participants This review will consider studies that include children, adults and elders who have type 2 diabetes and are controlling their fasting blood sugars with oral hypoglycemic agents and insulin. If the patients with type 2 diabetes in the selected studies indicate variant individual characteristics such as age (i.e., young children or very old people), co-morbidities and other chronic diseases, they will be sub-grouped according to these characteristics. Sub-group analyses will shed light on nuances in efficacy and harm/safety of bitter melon in individuals with different characteristics. Types of intervention(s) and comparator(s) This review will consider quantitative studies that have evaluated the effectiveness of any dose of bitter melon as an alternative to traditional hypoglycemic agents for the treatment of type 2 diabetes mellitus. Studies that have examined the effectiveness of interventions using all variations of frequencies and dosages of bitter melon will be considered. The review will also adopt an inclusive approach with respect to mode of administration with all different types of administration, such as bitter melon taken in fresh fruit, juice, tea, capsules and tablets to be considered for inclusion. This review will consider as comparators: (1) the use of placebos, (2) the use of pharmacotherapy alone or in conjunction with the standard diet (excluding the use of bitter melon) that is recommended to patients with type 2 diabetes. Types of outcomes This review will consider studies that have measured impact on the following outcomes using a range of measures: (1) fasting blood sugars, Hba1c, (2) safety/harmful effects of bitter melon on patients with type 2 diabetes. Whilst these are the outcomes for which results will be sought, additional outcomes for which results are presented in studies that meet the inclusion criteria and pass critical appraisal will be considered.