MOTS-c in type 2 diabetes mellitus — evidence extract

§1Evidence extract: Type 2 diabetes mellitus

§1.1Question and anchor outcome

Population

A disorder of glucose regulation characterised by insulin resistance with relative insulin deficiency, diagnosed by glycated haemoglobin, fasting plasma glucose or oral glucose tolerance criteria.

Intervention

MOTS-c, intraperitoneal and subcutaneous in preclinical studies; subcutaneous in research contexts

Comparator

As used in each contributing trial; reported per trial rather than pooled across comparator types

Anchor outcome

Change in HbA1c (%, mmol/mol)

Additional outcomes the Institute extracts for this indication: Proportion achieving HbA1c <7.0 % and ≤6.5 %; Change in fasting serum glucose; Change in body weight; Documented symptomatic hypoglycaemia.

§1.2Contributing trials

No trial has been identified for MOTS-c in type 2 diabetes mellitus. No certainty rating is issued where that is so, for the reason given at §1.3.

§1.3Why no certainty rating is issued

The Institute rates certainty in a body of evidence. Where no eligible study has been identified there is no such body, and the domain-by-domain assessment used elsewhere in this series is not rendered: an inconsistency judgement requires two estimates to be inconsistent with one another, and an imprecision judgement requires an interval. Neither exists here.

The outcome is therefore recorded as not assessed. It is listed in the certainty index under that heading rather than at the lowest rating, because a rating of very low certainty says that evidence was found and is weak, and that is not what has happened.

What would change this: a controlled study in the population stated at §1.1, reporting the anchor outcome, retrievable in a form the Institute can appraise. The evidence gaps recorded in the monograph at §9 state what such a study would need to measure.

§1.4What this extract does not establish

References cited on this page

References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.

1. Lee C, Zeng J, Drew BG, Sallam T, Martin-Montalvo A, Wan J, Kim SJ, Mehta H, Hevener AL, de Cabo R, Cohen P. The mitochondrial-derived peptide MOTS-c promotes metabolic homeostasis and reduces obesity and insulin resistance. Cell Metabolism 2015;21(3):443–454. doi:10.1016/j.cmet.2015.02.009 · PMID 25738459
2. D’Hondt M, Bracke N, Taevernier L, Gevaert B, Verbeke F, Wynendaele E, De Spiegeleer B. Related impurities in peptide medicines. Journal of Pharmaceutical and Biomedical Analysis 2014;101:2–30. doi:10.1016/j.jpba.2014.06.012 · PMID 25044089
3. Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. Stability of protein pharmaceuticals: an update. Pharmaceutical Research 2010;27(4):544–575. doi:10.1007/s11095-009-0045-6 · PMID 20143256

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